<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/NCT02982655</url>
  </required_header>
  <id_info>
    <org_study_id>KY20162085-2</org_study_id>
    <nct_id>NCT02982655</nct_id>
  </id_info>
  <brief_title>Controlling Hypertension After Severe Cerebrovascular Event</brief_title>
  <acronym>CHASE</acronym>
  <official_title>A Multi-center Randomised Controlled Trial to Explore the Ideal Individualized Anti-hypertension Strategies in Patients With Severe Stroke at Acute Stage</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xijing Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tang-Du Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xi'an Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shaanxi Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hanzhong Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Yan'an University Affiliated Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xiangyang Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xi'an 141 Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shangluo Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>215 Hospital of Shaanxi NI</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Yulin No.2 Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Yulin No.1 Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ankang Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital Xi'an Jiaotong University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xi'an Gaoxin Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>521 Hospital of NORINCO Group</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Xi'an Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xi'an No.3 Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xi'an No.4 Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xi'an No.9 Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xi'an XD Group Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xi'an Traditional Chinese Medicine Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Baoji Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Weinan Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tongchuan Mining Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tongchuan People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Xijing Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this academic lead study is to explore ideal blood pressure targets and&#xD;
      optimum individualized anti-hypertension strategies in acute severe stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Of high mortality and morbidity, severe stroke is associated with devastating damages in&#xD;
      neurologic, respiratory, circulatory and many other systems. The outcomes of patients with&#xD;
      severe stroke depend largely on medical strategies on acute stage, especially on blood&#xD;
      pressure (BP) management. Unfortunately, so far no ideal BP range has been scientifically&#xD;
      determined for patients with acute severe stroke.&#xD;
&#xD;
      The CHASE study aims to provide reliable data on the effects of individualized&#xD;
      anti-hypertension strategy in patients with acute severe stroke (target recruitment 250)&#xD;
      compared to standard guideline-based management of BP (target recruitment 250). Patients&#xD;
      presenting with acute (&lt;72h) severe stroke (GCS ≦ 12 or NIHSS ≧ 11) and elevated BP (systolic&#xD;
      blood pressure ≧150 mmHg or diastolic blood pressure ≧ 100 mmHg) will be randomly assigned to&#xD;
      individualized anti-hypertension treatment or guideline-based treatment for 7 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">November 30, 2018</completion_date>
  <primary_completion_date type="Actual">November 30, 2018</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Death or major disability (the modified Rankin scale ≥ 3)</measure>
    <time_frame>3 months after onset</time_frame>
    <description>Components of modified Rankin Scale score:0,No symptoms;1,No significant disability despite symptoms;2,Slight disability;3,Moderate disability requiring some help, but able to walk without assistance;4,Moderate severe disability;5,Severe disability;6,Death.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ability of activities of daily living at day 90 of enrollment (defined by Barthel Index)</measure>
    <time_frame>3 months after onset</time_frame>
    <description>Barthel Index is a 100-point scale (0-100), where higher scores indicate better ability of activities of daily living</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Severe Stroke</condition>
  <condition>Acute Stroke</condition>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Individualized BP lowering</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Management policy is to lower the systolic or diastolic BP by 10-15% within 2 hours of randomization and sustained for 7 days. Sites were provided with protocols for different intravenous agents and used whichever routinely available drugs were in their hospital.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Guideline recommended BP lowering</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients received management of BP based on the standard guidelines at the time, as published by the Chinese Society of Neurology (CSN) in 2014. The attending clinician may consider commencing BP treatment and sustained for 7 days if the systolic BP &gt; 200 mmHg or diastolic BP &gt;110 mmHg in patients with ischemic stroke, and systolic BP &gt; 180 mmHg or diastolic BP &gt; 110 mmHg in patients with cerebral hemorrhage.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Individualized BP lowering</intervention_name>
    <arm_group_label>Guideline recommended BP lowering</arm_group_label>
    <arm_group_label>Individualized BP lowering</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age ≥ 18 years;&#xD;
&#xD;
          2. the randomly assigned BP-lowering regimen is able to be commenced within 72 h after&#xD;
             the onset of stroke (ischemic or hemorrhagic), confirmed by a computed tomography (CT)&#xD;
             or magnetic resonance imaging (MRI) scan of the brain (if the precise timing of the&#xD;
             onset of symptoms or signs of the qualifying event is unknown, then the time of onset&#xD;
             will be taken as the last time the patient was known to be well);&#xD;
&#xD;
          3. GCS on admission ≤ 12 or NIHSS on admission ≥ 11;&#xD;
&#xD;
          4. there are at least two SBP measurements of ≥ 150 and ≤ 210 mmHg, recorded ≥5 min apart&#xD;
             (patients with an initial SBP &lt; 150 mmHg may be randomized when the SBP fulfils entry&#xD;
             criteria on rechecking up to 72 h after the onset of stroke);&#xD;
&#xD;
          5. written informed consent is able to be obtained directly from the patient or an&#xD;
             appropriate surrogate, based on local ethics committee recommendations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. patients who have received thrombolytic therapy, embolectomy, or decompressive&#xD;
             craniectomy for the current stroke;&#xD;
&#xD;
          2. patients with subarachnoid hemorrhage;&#xD;
&#xD;
          3. known definite contraindication to acute BP lowering (e.g. known severe carotid,&#xD;
             vertebral, or cerebral arterial stenosis, Moyamoya disease or Takayasu's arteritis,&#xD;
             high grade stenotic valvular heart disease);&#xD;
&#xD;
          4. secondary to a structural abnormality in the brain (e.g. an arteriovenous&#xD;
             malformation, intracranial aneurysm, tumor, or trauma);&#xD;
&#xD;
          5. unstable vital signs and requiring the use of vasoactive agents;&#xD;
&#xD;
          6. known existing dementia or prestroke disability (e.g. score 3-5 on the modified Rankin&#xD;
             scale);&#xD;
&#xD;
          7. concomitant medical illness that would interfere with the outcome assessments and/or&#xD;
             follow-up (advanced cancer; severe pulmonary dysfunction [forced expiratory volume in&#xD;
             1 s &lt; 50%]; severe cardiac dysfunction [ejection fraction ≤ 50%]; severe hepatic&#xD;
             failure [Child-Pugh score ≥ 7]; severe renal failure [glomerular filtration rate ≤ 30&#xD;
             mL/min or serum creatinine ≥ 4 mg/dL]);&#xD;
&#xD;
          8. patients who are currently participating in other investigational trials;&#xD;
&#xD;
          9. patients who are considered to have a high likelihood of not adhering to the study&#xD;
             treatment or the follow-up regimen.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wen Jiang, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Department of Neurology, Xijing Hospital, Fourth Military Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ankang Central Hospital</name>
      <address>
        <city>Ankang</city>
        <state>Shaanxi</state>
        <zip>725000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baoji Central Hospital</name>
      <address>
        <city>Baoji</city>
        <state>Shaanxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hanzhong Central Hospital</name>
      <address>
        <city>Hanzhong</city>
        <state>Shaanxi</state>
        <zip>710000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shangluo Central Hospital</name>
      <address>
        <city>Shangluo</city>
        <state>Shaanxi</state>
        <zip>726000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tongchuan Mining Hospital</name>
      <address>
        <city>Tongchuan</city>
        <state>Shaanxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tongchuan People's Hospital</name>
      <address>
        <city>Tongchuan</city>
        <state>Shaanxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weinan Central Hospital</name>
      <address>
        <city>Weinan</city>
        <state>Shaanxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xi'an 141 Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Neurology, Xijing Hospital, Fourth Military Medical University</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tangdu Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710038</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Xi'an Jiaotong University</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710061</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shaanxi Provincial People's Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710068</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>521 Hospital of NORINCO Group</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Xi'an Medical University</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xi'an Central Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xi'an Gaoxin Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xi'an No.3 Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xi'an No.4 Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xi'an No.9 Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xi'an Traditional Chinese Medicine Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xi'an XD Group Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xianyang Central Hospital</name>
      <address>
        <city>Xianyang</city>
        <state>Shaanxi</state>
        <zip>712000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>215 Hospital of Shaanxi NI</name>
      <address>
        <city>Xianyang</city>
        <state>Shaanxi</state>
        <zip>712021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yan'an University Affiliated Hospital</name>
      <address>
        <city>Ya'an</city>
        <state>Shaanxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yulin No.2 Hospital</name>
      <address>
        <city>Yulin</city>
        <state>Shaanxi</state>
        <zip>719000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yulin No.1 Hospital</name>
      <address>
        <city>Yulin</city>
        <state>Shaanxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Sandset EC, Bath PM, Boysen G, Jatuzis D, Korv J, Luders S, Murray GD, Richter PS, Roine RO, Terent A, Thijs V, Berge E; SCAST Study Group. The angiotensin-receptor blocker candesartan for treatment of acute stroke (SCAST): a randomised, placebo-controlled, double-blind trial. Lancet. 2011 Feb 26;377(9767):741-50. doi: 10.1016/S0140-6736(11)60104-9.</citation>
    <PMID>21316752</PMID>
  </reference>
  <reference>
    <citation>Vemmos KN, Spengos K, Tsivgoulis G, Zakopoulos N, Manios E, Kotsis V, Daffertshofer M, Vassilopoulos D. Factors influencing acute blood pressure values in stroke subtypes. J Hum Hypertens. 2004 Apr;18(4):253-9. doi: 10.1038/sj.jhh.1001662.</citation>
    <PMID>15037874</PMID>
  </reference>
  <reference>
    <citation>AlSibai A, Qureshi AI. Management of Acute Hypertensive Response in Patients With Ischemic Stroke. Neurohospitalist. 2016 Jul;6(3):122-9. doi: 10.1177/1941874416630029. Epub 2016 Apr 21.</citation>
    <PMID>27366297</PMID>
  </reference>
  <reference>
    <citation>Jauch EC, Saver JL, Adams HP Jr, Bruno A, Connors JJ, Demaerschalk BM, Khatri P, McMullan PW Jr, Qureshi AI, Rosenfield K, Scott PA, Summers DR, Wang DZ, Wintermark M, Yonas H; American Heart Association Stroke Council; Council on Cardiovascular Nursing; Council on Peripheral Vascular Disease; Council on Clinical Cardiology. Guidelines for the early management of patients with acute ischemic stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Mar;44(3):870-947. doi: 10.1161/STR.0b013e318284056a. Epub 2013 Jan 31.</citation>
    <PMID>23370205</PMID>
  </reference>
  <results_reference>
    <citation>CAST: randomised placebo-controlled trial of early aspirin use in 20,000 patients with acute ischaemic stroke. CAST (Chinese Acute Stroke Trial) Collaborative Group. Lancet. 1997 Jun 7;349(9066):1641-9.</citation>
    <PMID>9186381</PMID>
  </results_reference>
  <results_reference>
    <citation>Qureshi AI, Ezzeddine MA, Nasar A, Suri MF, Kirmani JF, Hussein HM, Divani AA, Reddi AS. Prevalence of elevated blood pressure in 563,704 adult patients with stroke presenting to the ED in the United States. Am J Emerg Med. 2007 Jan;25(1):32-8. doi: 10.1016/j.ajem.2006.07.008.</citation>
    <PMID>17157679</PMID>
  </results_reference>
  <results_reference>
    <citation>Castillo J, Leira R, Garcia MM, Serena J, Blanco M, Davalos A. Blood pressure decrease during the acute phase of ischemic stroke is associated with brain injury and poor stroke outcome. Stroke. 2004 Feb;35(2):520-6. doi: 10.1161/01.STR.0000109769.22917.B0. Epub 2004 Jan 15.</citation>
    <PMID>14726553</PMID>
  </results_reference>
  <results_reference>
    <citation>Schrader J, Luders S, Kulschewski A, Berger J, Zidek W, Treib J, Einhaupl K, Diener HC, Dominiak P; Acute Candesartan Cilexetil Therapy in Stroke Survivors Study Group. The ACCESS Study: evaluation of Acute Candesartan Cilexetil Therapy in Stroke Survivors. Stroke. 2003 Jul;34(7):1699-703. doi: 10.1161/01.STR.0000075777.18006.89. Epub 2003 Jun 19.</citation>
    <PMID>12817109</PMID>
  </results_reference>
  <results_reference>
    <citation>Potter JF, Robinson TG, Ford GA, Mistri A, James M, Chernova J, Jagger C. Controlling hypertension and hypotension immediately post-stroke (CHHIPS): a randomised, placebo-controlled, double-blind pilot trial. Lancet Neurol. 2009 Jan;8(1):48-56. doi: 10.1016/S1474-4422(08)70263-1. Epub 2008 Dec 4.</citation>
    <PMID>19058760</PMID>
  </results_reference>
  <results_reference>
    <citation>Robinson TG, Potter JF, Ford GA, Bulpitt CJ, Chernova J, Jagger C, James MA, Knight J, Markus HS, Mistri AK, Poulter NR; COSSACS Investigators. Effects of antihypertensive treatment after acute stroke in the Continue or Stop Post-Stroke Antihypertensives Collaborative Study (COSSACS): a prospective, randomised, open, blinded-endpoint trial. Lancet Neurol. 2010 Aug;9(8):767-75. doi: 10.1016/S1474-4422(10)70163-0.</citation>
    <PMID>20621562</PMID>
  </results_reference>
  <results_reference>
    <citation>He J, Zhang Y, Xu T, Zhao Q, Wang D, Chen CS, Tong W, Liu C, Xu T, Ju Z, Peng Y, Peng H, Li Q, Geng D, Zhang J, Li D, Zhang F, Guo L, Sun Y, Wang X, Cui Y, Li Y, Ma D, Yang G, Gao Y, Yuan X, Bazzano LA, Chen J; CATIS Investigators. Effects of immediate blood pressure reduction on death and major disability in patients with acute ischemic stroke: the CATIS randomized clinical trial. JAMA. 2014 Feb 5;311(5):479-89. doi: 10.1001/jama.2013.282543.</citation>
    <PMID>24240777</PMID>
  </results_reference>
  <results_reference>
    <citation>Anderson CS, Huang Y, Wang JG, Arima H, Neal B, Peng B, Heeley E, Skulina C, Parsons MW, Kim JS, Tao QL, Li YC, Jiang JD, Tai LW, Zhang JL, Xu E, Cheng Y, Heritier S, Morgenstern LB, Chalmers J; INTERACT Investigators. Intensive blood pressure reduction in acute cerebral haemorrhage trial (INTERACT): a randomised pilot trial. Lancet Neurol. 2008 May;7(5):391-9. doi: 10.1016/S1474-4422(08)70069-3. Epub 2008 Apr 7.</citation>
    <PMID>18396107</PMID>
  </results_reference>
  <results_reference>
    <citation>Anderson CS, Heeley E, Huang Y, Wang J, Stapf C, Delcourt C, Lindley R, Robinson T, Lavados P, Neal B, Hata J, Arima H, Parsons M, Li Y, Wang J, Heritier S, Li Q, Woodward M, Simes RJ, Davis SM, Chalmers J; INTERACT2 Investigators. Rapid blood-pressure lowering in patients with acute intracerebral hemorrhage. N Engl J Med. 2013 Jun 20;368(25):2355-65. doi: 10.1056/NEJMoa1214609. Epub 2013 May 29.</citation>
    <PMID>23713578</PMID>
  </results_reference>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>November 27, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>March 30, 2019</last_update_submitted>
  <last_update_submitted_qc>March 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Severe Stroke</keyword>
  <keyword>Acute Stroke</keyword>
  <keyword>Antihypertension</keyword>
  <keyword>mortality</keyword>
  <keyword>disability</keyword>
  <keyword>clinical trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT02982655
org study id: KY20162085-2
nct id: NCT02982655
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has dmc: Yes
The purpose of this academic lead study is to explore ideal blood pressure targets and
      optimum individualized anti-hypertension strategies in acute severe stroke.
Of high mortality and morbidity, severe stroke is associated with devastating damages in
      neurologic, respiratory, circulatory and many other systems. The outcomes of patients with
      severe stroke depend largely on medical strategies on acute stage, especially on blood
      pressure (BP) management. Unfortunately, so far no ideal BP range has been scientifically
      determined for patients with acute severe stroke.

      The CHASE study aims to provide reliable data on the effects of individualized
      anti-hypertension strategy in patients with acute severe stroke (target recruitment 250)
      compared to standard guideline-based management of BP (target recruitment 250). Patients
      presenting with acute (<72h) severe stroke (GCS ≦ 12 or NIHSS ≧ 11) and elevated BP (systolic
      blood pressure ≧150 mmHg or diastolic blood pressure ≧ 100 mmHg) will be randomly assigned to
      individualized anti-hypertension treatment or guideline-based treatment for 7 days.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Death or major disability (the modified Rankin scale ≥ 3)
time frame: 3 months after onset
description: Components of modified Rankin Scale score:0,No symptoms;1,No significant disability despite symptoms;2,Slight disability;3,Moderate disability requiring some help, but able to walk without assistance;4,Moderate severe disability;5,Severe disability;6,Death.
measure: Ability of activities of daily living at day 90 of enrollment (defined by Barthel Index)
time frame: 3 months after onset
description: Barthel Index is a 100-point scale (0-100), where higher scores indicate better ability of activities of daily living
arm group label: Individualized BP lowering
arm group type: Experimental
description: Management policy is to lower the systolic or diastolic BP by 10-15% within 2 hours of randomization and sustained for 7 days. Sites were provided with protocols for different intravenous agents and used whichever routinely available drugs were in their hospital.
arm group label: Guideline recommended BP lowering
arm group type: Active Comparator
description: Patients received management of BP based on the standard guidelines at the time, as published by the Chinese Society of Neurology (CSN) in 2014. The attending clinician may consider commencing BP treatment and sustained for 7 days if the systolic BP > 200 mmHg or diastolic BP >110 mmHg in patients with ischemic stroke, and systolic BP > 180 mmHg or diastolic BP > 110 mmHg in patients with cerebral hemorrhage.
intervention type: Procedure
intervention name: Individualized BP lowering
arm group label: Guideline recommended BP lowering
arm group label: Individualized BP lowering
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Wen Jiang, PhD
role: Study Director
affiliation: Department of Neurology, Xijing Hospital, Fourth Military Medical University
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country: China
citation: Sandset EC, Bath PM, Boysen G, Jatuzis D, Korv J, Luders S, Murray GD, Richter PS, Roine RO, Terent A, Thijs V, Berge E; SCAST Study Group. The angiotensin-receptor blocker candesartan for treatment of acute stroke (SCAST): a randomised, placebo-controlled, double-blind trial. Lancet. 2011 Feb 26;377(9767):741-50. doi: 10.1016/S0140-6736(11)60104-9.
PMID: 21316752
citation: Vemmos KN, Spengos K, Tsivgoulis G, Zakopoulos N, Manios E, Kotsis V, Daffertshofer M, Vassilopoulos D. Factors influencing acute blood pressure values in stroke subtypes. J Hum Hypertens. 2004 Apr;18(4):253-9. doi: 10.1038/sj.jhh.1001662.
PMID: 15037874
citation: AlSibai A, Qureshi AI. Management of Acute Hypertensive Response in Patients With Ischemic Stroke. Neurohospitalist. 2016 Jul;6(3):122-9. doi: 10.1177/1941874416630029. Epub 2016 Apr 21.
PMID: 27366297
citation: Jauch EC, Saver JL, Adams HP Jr, Bruno A, Connors JJ, Demaerschalk BM, Khatri P, McMullan PW Jr, Qureshi AI, Rosenfield K, Scott PA, Summers DR, Wang DZ, Wintermark M, Yonas H; American Heart Association Stroke Council; Council on Cardiovascular Nursing; Council on Peripheral Vascular Disease; Council on Clinical Cardiology. Guidelines for the early management of patients with acute ischemic stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Mar;44(3):870-947. doi: 10.1161/STR.0b013e318284056a. Epub 2013 Jan 31.
PMID: 23370205
citation: CAST: randomised placebo-controlled trial of early aspirin use in 20,000 patients with acute ischaemic stroke. CAST (Chinese Acute Stroke Trial) Collaborative Group. Lancet. 1997 Jun 7;349(9066):1641-9.
PMID: 9186381
citation: Qureshi AI, Ezzeddine MA, Nasar A, Suri MF, Kirmani JF, Hussein HM, Divani AA, Reddi AS. Prevalence of elevated blood pressure in 563,704 adult patients with stroke presenting to the ED in the United States. Am J Emerg Med. 2007 Jan;25(1):32-8. doi: 10.1016/j.ajem.2006.07.008.
PMID: 17157679
citation: Castillo J, Leira R, Garcia MM, Serena J, Blanco M, Davalos A. Blood pressure decrease during the acute phase of ischemic stroke is associated with brain injury and poor stroke outcome. Stroke. 2004 Feb;35(2):520-6. doi: 10.1161/01.STR.0000109769.22917.B0. Epub 2004 Jan 15.
PMID: 14726553
citation: Schrader J, Luders S, Kulschewski A, Berger J, Zidek W, Treib J, Einhaupl K, Diener HC, Dominiak P; Acute Candesartan Cilexetil Therapy in Stroke Survivors Study Group. The ACCESS Study: evaluation of Acute Candesartan Cilexetil Therapy in Stroke Survivors. Stroke. 2003 Jul;34(7):1699-703. doi: 10.1161/01.STR.0000075777.18006.89. Epub 2003 Jun 19.
PMID: 12817109
citation: Potter JF, Robinson TG, Ford GA, Mistri A, James M, Chernova J, Jagger C. Controlling hypertension and hypotension immediately post-stroke (CHHIPS): a randomised, placebo-controlled, double-blind pilot trial. Lancet Neurol. 2009 Jan;8(1):48-56. doi: 10.1016/S1474-4422(08)70263-1. Epub 2008 Dec 4.
PMID: 19058760
citation: Robinson TG, Potter JF, Ford GA, Bulpitt CJ, Chernova J, Jagger C, James MA, Knight J, Markus HS, Mistri AK, Poulter NR; COSSACS Investigators. Effects of antihypertensive treatment after acute stroke in the Continue or Stop Post-Stroke Antihypertensives Collaborative Study (COSSACS): a prospective, randomised, open, blinded-endpoint trial. Lancet Neurol. 2010 Aug;9(8):767-75. doi: 10.1016/S1474-4422(10)70163-0.
PMID: 20621562
citation: He J, Zhang Y, Xu T, Zhao Q, Wang D, Chen CS, Tong W, Liu C, Xu T, Ju Z, Peng Y, Peng H, Li Q, Geng D, Zhang J, Li D, Zhang F, Guo L, Sun Y, Wang X, Cui Y, Li Y, Ma D, Yang G, Gao Y, Yuan X, Bazzano LA, Chen J; CATIS Investigators. Effects of immediate blood pressure reduction on death and major disability in patients with acute ischemic stroke: the CATIS randomized clinical trial. JAMA. 2014 Feb 5;311(5):479-89. doi: 10.1001/jama.2013.282543.
PMID: 24240777
citation: Anderson CS, Huang Y, Wang JG, Arima H, Neal B, Peng B, Heeley E, Skulina C, Parsons MW, Kim JS, Tao QL, Li YC, Jiang JD, Tai LW, Zhang JL, Xu E, Cheng Y, Heritier S, Morgenstern LB, Chalmers J; INTERACT Investigators. Intensive blood pressure reduction in acute cerebral haemorrhage trial (INTERACT): a randomised pilot trial. Lancet Neurol. 2008 May;7(5):391-9. doi: 10.1016/S1474-4422(08)70069-3. Epub 2008 Apr 7.
PMID: 18396107
citation: Anderson CS, Heeley E, Huang Y, Wang J, Stapf C, Delcourt C, Lindley R, Robinson T, Lavados P, Neal B, Hata J, Arima H, Parsons M, Li Y, Wang J, Heritier S, Li Q, Woodward M, Simes RJ, Davis SM, Chalmers J; INTERACT2 Investigators. Rapid blood-pressure lowering in patients with acute intracerebral hemorrhage. N Engl J Med. 2013 Jun 20;368(25):2355-65. doi: 10.1056/NEJMoa1214609. Epub 2013 May 29.
PMID: 23713578
responsible party type: Sponsor
mesh term: Stroke
mesh term: Hypertension
sharing ipd: Undecided