<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03015311</url>
  </required_header>
  <id_info>
    <org_study_id>2016CXGC07</org_study_id>
    <secondary_id>2016-I2M-1-006</secondary_id>
    <nct_id>NCT03015311</nct_id>
  </id_info>
  <brief_title>Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients</brief_title>
  <acronym>STEP</acronym>
  <official_title>Strategy of Systolic Blood Pressure Intervention in the Elderly Hypertensive Patients: A Prospective Randomized Open-Label Blinded-Endpoint Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese Academy of Medical Sciences, Fuwai Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese Academy of Medical Sciences, Fuwai Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients (STEP) is a&#xD;
      2-arm, multi-center, prospective, randomized, open-labeled, blinded-endpoint trial. The&#xD;
      purpose of this trial is to test whether a treatment program aimed at reducing systolic blood&#xD;
      pressure (SBP) to a lower goal (&lt;130 mmHg, intensive treatment) than currently recommended&#xD;
      (&lt;150 mmHg, standard treatment) will reduce CVD risk among persons between 60-80 years of&#xD;
      old. Furthermore, this trial will also examine the effect of blood pressure APP management&#xD;
      strategy via WeChat network on medication compliance, blood pressure control and CVD&#xD;
      benefits.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypertension is highly prevalent in the adult population in China, and its burden is rapidly&#xD;
      increasing among persons older than 60 years of age. Elevated blood pressure (BP) is an&#xD;
      important public health concern which contributes to several adverse health outcomes,&#xD;
      especially coronary heart disease, stroke, heart failure, chronic kidney disease, and decline&#xD;
      in cognitive function. Clinical trials have shown that a lower systolic blood pressure goal&#xD;
      will lead to greater reduction in cardiovascular disease (CVD) incidence, but the effect of&#xD;
      intensive treatment of systolic blood pressure below 120 mm Hg in reducing of CVD risk has&#xD;
      long been debated. In particularly, among the elderly hypertensive patients aged 60 years or&#xD;
      older, the most appropriate targets for blood pressure lowering to reduce cardiovascular&#xD;
      events still remain uncertain.&#xD;
&#xD;
      The STEP trial will randomize about 8000 participants aged between 60 and 80 years with&#xD;
      SBP≥140 mm Hg and &lt;190 mm Hg, and without a history of atherothrombotic or hemorrhagic&#xD;
      stroke. Target SBP goals are 110-130 vs 130-150 mm Hg, respectively. The purpose of the STEP&#xD;
      trial is to test whether a treatment program aimed at reducing systolic blood pressure (SBP)&#xD;
      to a lower goal (&lt;130 mmHg, intensive treatment) than currently recommended (&lt;150 mmHg,&#xD;
      standard treatment) will reduce CVD risk among hypertensive patients between 60-80 years.&#xD;
      Participants will be recruited at approximately 40 clinic centers in China within&#xD;
      approximately a 1-year period, and will be followed for 4 years. Furthermore, this trial will&#xD;
      also examine the effect of blood pressure APP management strategy via WeChat network on&#xD;
      medication compliance, blood pressure control and CVD benefits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 15, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary composite outcome</measure>
    <time_frame>4 years</time_frame>
    <description>A composite end-point comprised of acute coronary syndrome (myocardial infarction and hospitalization for unstable angina), first occurrence of symptomatic stroke ( ischemic or hemorrhagic stroke), hospitalization for decompensated heart failure, coronary revascularization (percutaneous coronary intervention [PCI], coronary artery bypass grafting [CABG]), atrial fibrillation, and death from cardiovascular causes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Composite of major adverse cardiac events (primary outcome without stroke)</measure>
    <time_frame>4 years</time_frame>
    <description>Composite of major adverse cardiac events comprised of acute coronary syndrome (myocardial infarction and hospitalization for unstable angina), hospitalization for decompensated heart failure, coronary revascularization (percutaneous coronary intervention [PCI], coronary artery bypass grafting [CABG]), atrial fibrillation, and death from cardiovascular causes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>First occurrence of symptomatic stroke ( ischemic or hemorrhagic)</measure>
    <time_frame>4 years</time_frame>
    <description>Stroke is defined as a rapid onset of focal (or global) disturbance of cerebral function lasting more than 24 hours (except interrupted by surgery or death) without resolution of symptoms according to the World Health Organization. The diagnosis of stroke is confirmed by strict neurological examination, computed tomography (CT), or magnetic resonance imaging (MRI), and stroke subtypes are classified including ischemic or hemorrhagic, fatal or not fatal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute coronary syndrome</measure>
    <time_frame>4 years</time_frame>
    <description>Acute coronary syndrome includes myocardial infarction and hospitalization for unstable angina. The diagnosis of MI is based on the following criteria: (1) Patient has cardiac signs and symptoms, such as retrosternal pain last for at least 30 minutes, and not relieve to nitroglycerine during the attack; (2) Electrocardiographic abnormal findings of MI are observed; (3) Biochemical markers of cardiac damage are present.&#xD;
The diagnosis of unstable angina requires hospitalization for evaluation. The clinical presentation of unstable angina includes: (1) prolonged (&gt;20 min) angina pain at rest; (2) new onset angina; (3) post-MI angina; (4) recent destabilization of previously stable angina with at least Canadian Cardiovascular Society Class III angina characteristics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalization for acute decompensated heart failure</measure>
    <time_frame>4 years</time_frame>
    <description>Diagnosis of acute decompensated heart failure requires a hospitalization or emergency department visit which provides an infusion therapy for clinical signs and symptoms consistent with cardiac decompensation or inadequate cardiac pump function, such as increasing or new onset shortness of breath, peripheral edema, paroxysmal dyspnea, orthopnea, or hypoxia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>coronary revascularization (percutaneous coronary intervention [PCI], coronary artery bypass grafting [CABG])</measure>
    <time_frame>4 years</time_frame>
    <description>Patients are treated with coronary revascularization by either PCI or CABG due to acute coronary syndromes (ACS) and stable ischemic heart disease (SIHD).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Atrial fibrillation</measure>
    <time_frame>4 years</time_frame>
    <description>Diagnosis of AF requires rhythm evidence of an ECG showing the typical pattern including absolutely irregular RR intervals and no discernible, distinct P waves.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular death</measure>
    <time_frame>4 years</time_frame>
    <description>Cardiovascular death includes fatal coronary heart disease, fatal stroke, death from heart failure, and sudden cardiac death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause death</measure>
    <time_frame>4 years</time_frame>
    <description>All-cause death includes death due to any reasons during the trial. Evidence for death includes death certificates from hospitals or reports of home visit from investigators.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>First occurrence of diabetes mellitus</measure>
    <time_frame>4 years</time_frame>
    <description>Diagnosis of incident diabetes mellitus includes the following criteria: (1) Fasting plasma glucose ≥ 126 mg/dl (≥ 7.0 mmol/dl); or (2) Oral glucose tolerance test 2-hour glucose in venous plasma ≥ 200 mg/dl (≥ 11.1 mmol/l); or (3) In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥ 200 mg/dl (≥ 11.1 mmol/l); or (4) Glycosylated hemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decline in cognitive function</measure>
    <time_frame>4 years</time_frame>
    <description>Decline in cognitive function includes sensory disturbance, memory disorders and thinking disorders, which is assessed by mini-mental state examination (MMSE)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decline in renal function or development of end stage renal disease (ESRD)</measure>
    <time_frame>4 years</time_frame>
    <description>Decline in renal function is assessed by any of the following: (1) For patients with chronic kidney disease (eGFR &lt;60 ml per minute per 1.73 m2) at baseline, the renal outcome was a composite of a decrease in the eGFR of 50% or more (confirmed by a subsequent laboratory test) or the development of ESRD requiring long-term dialysis or kidney transplantation; or (2) For participants without chronic kidney disease at baseline, the renal outcome was defined by a decrease in the eGFR of 30% or more to a value of less than 60 ml per minute per 1.73 m2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major artery stiffness</measure>
    <time_frame>4 years</time_frame>
    <description>Major artery stiffness are assessed by a composite of decrease in the ankle brachial index [ABI], brachial-ankle pulse wave velocity(baPWV), or brachial artery flow-mediated dilation [FMD].&#xD;
ABI and baPWV,well-established non-invasive techniques for evaluating obstruction and stiffness of peripheral artery respectively, are considered for the purposes of cardiovascular risk assessment. ABI is the ratio of the average systolic blood pressure measured in brachial/ankle, and an ABI between and including 0.9 and 1.2 is considered normal, while a lesser than 0.9 indicates arterial disease. The unit measure of baPWV value is cm per second.&#xD;
FMD serves as an index of nitric oxide (NO)-mediated endothelium-dependent vasodilator function in humans and is regarded as a surrogate marker of cardiovascular disease.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">8000</enrollment>
  <condition>Primary Hypertension</condition>
  <arm_group>
    <arm_group_label>Intensive BP control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SBP within 110 - &lt;130 mm Hg. Participants randomized into the Intensive BP control arm will have a goal of SBP 110 - &lt;130 mm Hg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard BP control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>SBP within 130 - &lt;150 mm Hg. Participants randomized into the Intensive BP control arm will have a goal of SBP 130 - &lt;150 mm Hg.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intensive BP control</intervention_name>
    <description>For all participants, Olmesartan Medoxomil tablets or Amlodipine Besylate tablets will be used as an initial therapy. Other drugs, including hydrochlorothiazide and β-blockers, are allowed, in order to achieve the SBP target. If the target BP level is not achieved during the Follow-up periods, adjustment of drug type and dosage will be carried out according to procedures defined in the protocol.</description>
    <arm_group_label>Intensive BP control</arm_group_label>
    <other_name>Lower target for reducing SBP</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard BP control</intervention_name>
    <description>For all participants, Olmesartan Medoxomil tablets or Amlodipine Besylate tablets will be used as an initial therapy. Other drugs, including hydrochlorothiazide and β-blockers, are allowed, in order to achieve the SBP target. If the target BP level is not achieved during the Follow-up periods, adjustment of drug type and dosage will be carried out according to procedures defined in the protocol.</description>
    <arm_group_label>Standard BP control</arm_group_label>
    <other_name>Standard target for reducing SBP</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Systolic BP between 140-190 mm Hg in the three screening visits or currently under&#xD;
             anti-hypertension treatment；&#xD;
&#xD;
          2. An age of 60 - 80 years old；&#xD;
&#xD;
          3. Signed the written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Systolic BP≥190 mm Hg, or diastolic BP &lt;60 mm Hg;&#xD;
&#xD;
          2. Known secondary cause of hypertension;&#xD;
&#xD;
          3. History of large atherosclerotic cerebral infarction or hemorrhagic stroke (not&#xD;
             lacunar infarction and transient ischemic attack [TIA]);&#xD;
&#xD;
          4. Hospitalization for myocardial infarction or unstable angina within the previous 6&#xD;
             months;&#xD;
&#xD;
          5. Coronary revascularization (PCI or CABG) within the previous 12 months;&#xD;
&#xD;
          6. Planned to perform coronary revascularization (PCI or CABG) in the future 12 months;&#xD;
&#xD;
          7. History of sustained atrial fibrillation or Ventricular arrhythmias at entry&#xD;
             influencing the measurement of electronic blood pressure；&#xD;
&#xD;
          8. NYHA class III-IV heart failure at entry or hospitalization for exacerbation of&#xD;
             chronic heart failure within the previous 6 months;&#xD;
&#xD;
          9. Severe valvular disease or valvular disease likely to require surgery or percutaneous&#xD;
             valve replacement during the trial;&#xD;
&#xD;
         10. Dilated or hypertrophic cardiomyopathy, rheumatic heart disease, or congenital heart&#xD;
             disease;&#xD;
&#xD;
         11. Uncontrolled diabetes (serum fasting glucose ≥200 mg/dl [11.1 mmol/L], HbA1&gt;8%);&#xD;
&#xD;
         12. Lab tests indicating abnormal liver or kidney function (ALT more than 3 times the&#xD;
             upper limit of normal value, or end stage renal disease (ESRD) on dialysis, or&#xD;
             estimated glomerular filtration rate (eGFR) &lt;30 mL/min, or serum creatine &gt;2.5 mg/dl&#xD;
             [&gt;221 umol/L];&#xD;
&#xD;
         13. Severe somatic disease such as cancer;&#xD;
&#xD;
         14. Severe cognitive impairment or mental disorders;&#xD;
&#xD;
         15. Participating in other clinical trials.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jun Cai, MD</last_name>
    <role>Study Director</role>
    <affiliation>Chinese Academy of Medical Sciences, Fuwai Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing Chaoyang Hospital affiliated to Capical Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100020</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bei Jing Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100037</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chinese Academy of Medical Sciences, FuWai Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100037</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xuanwu hospital of capital medical university</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100053</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Pinggu Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lanzhou University Second Hospital</name>
      <address>
        <city>Lanzhou</city>
        <state>Gansu</state>
        <zip>730030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangdong Cardiovascular Institute</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huizhou Municipal Central Hospital</name>
      <address>
        <city>Huizhou</city>
        <state>Guangdong</state>
        <zip>516001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital to Medical College Shantou University Guangdong</name>
      <address>
        <city>Shantou</city>
        <state>Guangdong</state>
        <zip>515041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shenzhen Sun Yat-sen Cardiovascular Hospital</name>
      <address>
        <city>Shenzhen</city>
        <state>Guangdong</state>
        <zip>518001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Guangxi Medical University</name>
      <address>
        <city>Nanning</city>
        <state>Guangxi</state>
        <zip>530021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Guangxi University of Chinese Medicine</name>
      <address>
        <city>Nanning</city>
        <state>Guangxi</state>
        <zip>530023</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kailua General Hospital</name>
      <address>
        <city>Tangshan</city>
        <state>Hebei</state>
        <zip>063000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Hebei North University</name>
      <address>
        <city>Zhangjiakou</city>
        <state>Hebei</state>
        <zip>075000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First affiliated Hospital of Harbin Medical University</name>
      <address>
        <city>Harbin</city>
        <state>Heilongjiang</state>
        <zip>150001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hong xinglong center hospital</name>
      <address>
        <city>Shuangyashan</city>
        <state>Heilongjiang</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Affiliated Hospitalof Zhengzhou University</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhoukou City Central Hospital</name>
      <address>
        <city>Zhoukou</city>
        <state>Henan</state>
        <zip>466000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Renmin Hospital of Wuhan University</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kang Ya Hospita</name>
      <address>
        <city>Yiyang</city>
        <state>Hunan</state>
        <zip>413000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Baotou Medical College</name>
      <address>
        <city>Baotou</city>
        <state>Inner Mongolia</state>
        <zip>014030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhenjiang First People's Hospital</name>
      <address>
        <city>Zhenjiang</city>
        <state>Jiangsu</state>
        <zip>212002</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>the Second Affiliated Hospitalof NanChang University</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <zip>330006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Benxi Railway Hospital</name>
      <address>
        <city>Benxi</city>
        <state>Liaoning</state>
        <zip>117000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The 1st Affiliated Hospital of Dalian Medical University</name>
      <address>
        <city>Dalian</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First People's Hospital of Yinchuan</name>
      <address>
        <city>Yinchuan</city>
        <state>Ningxia</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Qilu Hospital of Shandong University</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250012</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jining First People's Hospital</name>
      <address>
        <city>Jining</city>
        <state>Shandong</state>
        <zip>272011</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai general hospital, Shanghai Jiaotong University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200080</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Hospital of Shanxi Medical University</name>
      <address>
        <city>Taiyuan</city>
        <state>Shanxi</state>
        <zip>030001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanxi caidiovascular hospital</name>
      <address>
        <city>Taiyuan</city>
        <state>Shanxi</state>
        <zip>030024</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanxi Academy of Medical Sciences, Shanxi Dayi Hospital</name>
      <address>
        <city>Taiyuan</city>
        <state>Shanxi</state>
        <zip>030032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Affiliated Hospital, Xian Jiaotong University</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <zip>710061</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West China Hospital, Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>College of Medicine , National Taiwan University</name>
      <address>
        <city>Taibei</city>
        <state>Taiwan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pingjin Hospital, Logistics University of PAPF</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300162</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>the People's Hospital of Ji Xian Distric</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Affiliated Hospital of Xinjiang Medical University</name>
      <address>
        <city>Urumqi</city>
        <state>Xinjiang</state>
        <zip>830054</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yan'an Hospital affiliated to kunming medical university, Yunnan Cardiovascular Hospital</name>
      <address>
        <city>Kunming</city>
        <state>Yunnan</state>
        <zip>650051</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Kunming Medical University</name>
      <address>
        <city>Kunming</city>
        <state>Yunnan</state>
        <zip>650101</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Kunming</name>
      <address>
        <city>Kunming</city>
        <state>Yunnan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Wang Y, Peng X, Nie X, Chen L, Weldon R, Zhang W, Xiao D, Cai J. Burden of hypertension in China over the past decades: Systematic analysis of prevalence, treatment and control of hypertension. Eur J Prev Cardiol. 2016 May;23(8):792-800. doi: 10.1177/2047487315617105. Epub 2015 Nov 24.</citation>
    <PMID>26603746</PMID>
  </reference>
  <reference>
    <citation>SPRINT Research Group; Wright JT Jr, Williamson JD, Whelton PK, Snyder JK, Sink KM, Rocco MV, Reboussin DM, Rahman M, Oparil S, Lewis CE, Kimmel PL, Johnson KC, Goff DC Jr, Fine LJ, Cutler JA, Cushman WC, Cheung AK, Ambrosius WT. A Randomized Trial of Intensive versus Standard Blood-Pressure Control. N Engl J Med. 2015 Nov 26;373(22):2103-16. doi: 10.1056/NEJMoa1511939. Epub 2015 Nov 9. Erratum In: N Engl J Med. 2017 Dec 21;377(25):2506.</citation>
    <PMID>26551272</PMID>
  </reference>
  <reference>
    <citation>ACCORD Study Group; Cushman WC, Evans GW, Byington RP, Goff DC Jr, Grimm RH Jr, Cutler JA, Simons-Morton DG, Basile JN, Corson MA, Probstfield JL, Katz L, Peterson KA, Friedewald WT, Buse JB, Bigger JT, Gerstein HC, Ismail-Beigi F. Effects of intensive blood-pressure control in type 2 diabetes mellitus. N Engl J Med. 2010 Apr 29;362(17):1575-85. doi: 10.1056/NEJMoa1001286. Epub 2010 Mar 14.</citation>
    <PMID>20228401</PMID>
  </reference>
  <reference>
    <citation>Probstfield JL, Applegate WB, Borhani NO, Curb JD, Cutler JA, Davis BR, Furberg CD, Hawkins CM, Lakatos E, Page LB, et al. The Systolic Hypertension in the Elderly Program (SHEP): an intervention trial on isolated systolic hypertension. SHEP Cooperative Research Group. Clin Exp Hypertens A. 1989;11(5-6):973-89. doi: 10.3109/10641968909035386.</citation>
    <PMID>2676266</PMID>
  </reference>
  <reference>
    <citation>JATOS Study Group. Principal results of the Japanese trial to assess optimal systolic blood pressure in elderly hypertensive patients (JATOS). Hypertens Res. 2008 Dec;31(12):2115-27. doi: 10.1291/hypres.31.2115.</citation>
    <PMID>19139601</PMID>
  </reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>January 2, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>July 22, 2021</last_update_submitted>
  <last_update_submitted_qc>July 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese Academy of Medical Sciences, Fuwai Hospital</investigator_affiliation>
    <investigator_full_name>Jun Cai</investigator_full_name>
    <investigator_title>Director, Hypertension Center</investigator_title>
  </responsible_party>
  <keyword>Blood pressure control</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Essential Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Within 3 years after the trial complete</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Within 3 years after the trial complete</ipd_time_frame>
    <ipd_access_criteria>To share IPD in the magazine of paper published</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03015311
org study id: 2016CXGC07
secondary id: 2016-I2M-1-006
nct id: NCT03015311
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients (STEP) is a
      2-arm, multi-center, prospective, randomized, open-labeled, blinded-endpoint trial. The
      purpose of this trial is to test whether a treatment program aimed at reducing systolic blood
      pressure (SBP) to a lower goal (<130 mmHg, intensive treatment) than currently recommended
      (<150 mmHg, standard treatment) will reduce CVD risk among persons between 60-80 years of
      old. Furthermore, this trial will also examine the effect of blood pressure APP management
      strategy via WeChat network on medication compliance, blood pressure control and CVD
      benefits.
Hypertension is highly prevalent in the adult population in China, and its burden is rapidly
      increasing among persons older than 60 years of age. Elevated blood pressure (BP) is an
      important public health concern which contributes to several adverse health outcomes,
      especially coronary heart disease, stroke, heart failure, chronic kidney disease, and decline
      in cognitive function. Clinical trials have shown that a lower systolic blood pressure goal
      will lead to greater reduction in cardiovascular disease (CVD) incidence, but the effect of
      intensive treatment of systolic blood pressure below 120 mm Hg in reducing of CVD risk has
      long been debated. In particularly, among the elderly hypertensive patients aged 60 years or
      older, the most appropriate targets for blood pressure lowering to reduce cardiovascular
      events still remain uncertain.

      The STEP trial will randomize about 8000 participants aged between 60 and 80 years with
      SBP≥140 mm Hg and <190 mm Hg, and without a history of atherothrombotic or hemorrhagic
      stroke. Target SBP goals are 110-130 vs 130-150 mm Hg, respectively. The purpose of the STEP
      trial is to test whether a treatment program aimed at reducing systolic blood pressure (SBP)
      to a lower goal (<130 mmHg, intensive treatment) than currently recommended (<150 mmHg,
      standard treatment) will reduce CVD risk among hypertensive patients between 60-80 years.
      Participants will be recruited at approximately 40 clinic centers in China within
      approximately a 1-year period, and will be followed for 4 years. Furthermore, this trial will
      also examine the effect of blood pressure APP management strategy via WeChat network on
      medication compliance, blood pressure control and CVD benefits.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Primary composite outcome
time frame: 4 years
description: A composite end-point comprised of acute coronary syndrome (myocardial infarction and hospitalization for unstable angina), first occurrence of symptomatic stroke ( ischemic or hemorrhagic stroke), hospitalization for decompensated heart failure, coronary revascularization (percutaneous coronary intervention [PCI], coronary artery bypass grafting [CABG]), atrial fibrillation, and death from cardiovascular causes.
measure: Composite of major adverse cardiac events (primary outcome without stroke)
time frame: 4 years
description: Composite of major adverse cardiac events comprised of acute coronary syndrome (myocardial infarction and hospitalization for unstable angina), hospitalization for decompensated heart failure, coronary revascularization (percutaneous coronary intervention [PCI], coronary artery bypass grafting [CABG]), atrial fibrillation, and death from cardiovascular causes.
measure: First occurrence of symptomatic stroke ( ischemic or hemorrhagic)
time frame: 4 years
description: Stroke is defined as a rapid onset of focal (or global) disturbance of cerebral function lasting more than 24 hours (except interrupted by surgery or death) without resolution of symptoms according to the World Health Organization. The diagnosis of stroke is confirmed by strict neurological examination, computed tomography (CT), or magnetic resonance imaging (MRI), and stroke subtypes are classified including ischemic or hemorrhagic, fatal or not fatal.
measure: Acute coronary syndrome
time frame: 4 years
description: Acute coronary syndrome includes myocardial infarction and hospitalization for unstable angina. The diagnosis of MI is based on the following criteria: (1) Patient has cardiac signs and symptoms, such as retrosternal pain last for at least 30 minutes, and not relieve to nitroglycerine during the attack; (2) Electrocardiographic abnormal findings of MI are observed; (3) Biochemical markers of cardiac damage are present.
The diagnosis of unstable angina requires hospitalization for evaluation. The clinical presentation of unstable angina includes: (1) prolonged (>20 min) angina pain at rest; (2) new onset angina; (3) post-MI angina; (4) recent destabilization of previously stable angina with at least Canadian Cardiovascular Society Class III angina characteristics.
measure: Hospitalization for acute decompensated heart failure
time frame: 4 years
description: Diagnosis of acute decompensated heart failure requires a hospitalization or emergency department visit which provides an infusion therapy for clinical signs and symptoms consistent with cardiac decompensation or inadequate cardiac pump function, such as increasing or new onset shortness of breath, peripheral edema, paroxysmal dyspnea, orthopnea, or hypoxia.
measure: coronary revascularization (percutaneous coronary intervention [PCI], coronary artery bypass grafting [CABG])
time frame: 4 years
description: Patients are treated with coronary revascularization by either PCI or CABG due to acute coronary syndromes (ACS) and stable ischemic heart disease (SIHD).
measure: Atrial fibrillation
time frame: 4 years
description: Diagnosis of AF requires rhythm evidence of an ECG showing the typical pattern including absolutely irregular RR intervals and no discernible, distinct P waves.
measure: Cardiovascular death
time frame: 4 years
description: Cardiovascular death includes fatal coronary heart disease, fatal stroke, death from heart failure, and sudden cardiac death.
measure: All-cause death
time frame: 4 years
description: All-cause death includes death due to any reasons during the trial. Evidence for death includes death certificates from hospitals or reports of home visit from investigators.
measure: First occurrence of diabetes mellitus
time frame: 4 years
description: Diagnosis of incident diabetes mellitus includes the following criteria: (1) Fasting plasma glucose ≥ 126 mg/dl (≥ 7.0 mmol/dl); or (2) Oral glucose tolerance test 2-hour glucose in venous plasma ≥ 200 mg/dl (≥ 11.1 mmol/l); or (3) In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥ 200 mg/dl (≥ 11.1 mmol/l); or (4) Glycosylated hemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol).
measure: Decline in cognitive function
time frame: 4 years
description: Decline in cognitive function includes sensory disturbance, memory disorders and thinking disorders, which is assessed by mini-mental state examination (MMSE)
measure: Decline in renal function or development of end stage renal disease (ESRD)
time frame: 4 years
description: Decline in renal function is assessed by any of the following: (1) For patients with chronic kidney disease (eGFR <60 ml per minute per 1.73 m2) at baseline, the renal outcome was a composite of a decrease in the eGFR of 50% or more (confirmed by a subsequent laboratory test) or the development of ESRD requiring long-term dialysis or kidney transplantation; or (2) For participants without chronic kidney disease at baseline, the renal outcome was defined by a decrease in the eGFR of 30% or more to a value of less than 60 ml per minute per 1.73 m2.
measure: Major artery stiffness
time frame: 4 years
description: Major artery stiffness are assessed by a composite of decrease in the ankle brachial index [ABI], brachial-ankle pulse wave velocity(baPWV), or brachial artery flow-mediated dilation [FMD].
ABI and baPWV,well-established non-invasive techniques for evaluating obstruction and stiffness of peripheral artery respectively, are considered for the purposes of cardiovascular risk assessment. ABI is the ratio of the average systolic blood pressure measured in brachial/ankle, and an ABI between and including 0.9 and 1.2 is considered normal, while a lesser than 0.9 indicates arterial disease. The unit measure of baPWV value is cm per second.
FMD serves as an index of nitric oxide (NO)-mediated endothelium-dependent vasodilator function in humans and is regarded as a surrogate marker of cardiovascular disease.
arm group label: Intensive BP control
arm group type: Experimental
description: SBP within 110 - <130 mm Hg. Participants randomized into the Intensive BP control arm will have a goal of SBP 110 - <130 mm Hg.
arm group label: Standard BP control
arm group type: Active Comparator
description: SBP within 130 - <150 mm Hg. Participants randomized into the Intensive BP control arm will have a goal of SBP 130 - <150 mm Hg.
intervention type: Drug
intervention name: Intensive BP control
description: For all participants, Olmesartan Medoxomil tablets or Amlodipine Besylate tablets will be used as an initial therapy. Other drugs, including hydrochlorothiazide and β-blockers, are allowed, in order to achieve the SBP target. If the target BP level is not achieved during the Follow-up periods, adjustment of drug type and dosage will be carried out according to procedures defined in the protocol.
arm group label: Intensive BP control
other name: Lower target for reducing SBP
intervention type: Drug
intervention name: Standard BP control
description: For all participants, Olmesartan Medoxomil tablets or Amlodipine Besylate tablets will be used as an initial therapy. Other drugs, including hydrochlorothiazide and β-blockers, are allowed, in order to achieve the SBP target. If the target BP level is not achieved during the Follow-up periods, adjustment of drug type and dosage will be carried out according to procedures defined in the protocol.
arm group label: Standard BP control
other name: Standard target for reducing SBP
criteria: 
gender: All
minimum age: 60 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jun Cai, MD
role: Study Director
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
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country: China
citation: Wang Y, Peng X, Nie X, Chen L, Weldon R, Zhang W, Xiao D, Cai J. Burden of hypertension in China over the past decades: Systematic analysis of prevalence, treatment and control of hypertension. Eur J Prev Cardiol. 2016 May;23(8):792-800. doi: 10.1177/2047487315617105. Epub 2015 Nov 24.
PMID: 26603746
citation: SPRINT Research Group; Wright JT Jr, Williamson JD, Whelton PK, Snyder JK, Sink KM, Rocco MV, Reboussin DM, Rahman M, Oparil S, Lewis CE, Kimmel PL, Johnson KC, Goff DC Jr, Fine LJ, Cutler JA, Cushman WC, Cheung AK, Ambrosius WT. A Randomized Trial of Intensive versus Standard Blood-Pressure Control. N Engl J Med. 2015 Nov 26;373(22):2103-16. doi: 10.1056/NEJMoa1511939. Epub 2015 Nov 9. Erratum In: N Engl J Med. 2017 Dec 21;377(25):2506.
PMID: 26551272
citation: ACCORD Study Group; Cushman WC, Evans GW, Byington RP, Goff DC Jr, Grimm RH Jr, Cutler JA, Simons-Morton DG, Basile JN, Corson MA, Probstfield JL, Katz L, Peterson KA, Friedewald WT, Buse JB, Bigger JT, Gerstein HC, Ismail-Beigi F. Effects of intensive blood-pressure control in type 2 diabetes mellitus. N Engl J Med. 2010 Apr 29;362(17):1575-85. doi: 10.1056/NEJMoa1001286. Epub 2010 Mar 14.
PMID: 20228401
citation: Probstfield JL, Applegate WB, Borhani NO, Curb JD, Cutler JA, Davis BR, Furberg CD, Hawkins CM, Lakatos E, Page LB, et al. The Systolic Hypertension in the Elderly Program (SHEP): an intervention trial on isolated systolic hypertension. SHEP Cooperative Research Group. Clin Exp Hypertens A. 1989;11(5-6):973-89. doi: 10.3109/10641968909035386.
PMID: 2676266
citation: JATOS Study Group. Principal results of the Japanese trial to assess optimal systolic blood pressure in elderly hypertensive patients (JATOS). Hypertens Res. 2008 Dec;31(12):2115-27. doi: 10.1291/hypres.31.2115.
PMID: 19139601
responsible party type: Principal Investigator
investigator affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
investigator full name: Jun Cai
investigator title: Director, Hypertension Center
mesh term: Essential Hypertension
sharing ipd: Yes
ipd description: Within 3 years after the trial complete
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Within 3 years after the trial complete
ipd access criteria: To share IPD in the magazine of paper published