<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/NCT01665235</url>
  </required_header>
  <id_info>
    <org_study_id>RenJiH-20120804</org_study_id>
    <nct_id>NCT01665235</nct_id>
  </id_info>
  <brief_title>Blood Pressure Variability and the Prognosis of Ischemic Stroke With Intracranial Artery Stenosis</brief_title>
  <official_title>The Correlation Study Between Blood Pressure Variability and the Prognosis of Ischemic Stroke With Intracranial Artery Stenosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RenJi Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>RenJi Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Correlation study about Blood Pressure Variability and the prognosis of ischemic stroke with&#xD;
      intracranial artery stenosis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Extracranial atherosclerotic stenosis is the main reason for the European and American white&#xD;
      ischemic stroke and transient ischemic attack,while Atherosclerotic intracranial arterial&#xD;
      stenosis is an important reason for Asian patients with stroke ,accounting for the 33% to 51%&#xD;
      of a etiology ratio.The latest research suggests that varying degrees of blood pressure&#xD;
      variability can affect the risk of stroke.This study observe the relationship between blood&#xD;
      pressure variability and prognosis of ischemic stroke patients with intracranial arterial&#xD;
      stenosis,with cranial magnetic resonance imaging (MRI + DWI),magnetic resonance angiography&#xD;
      and Trans-cranial Doppler(TCD) .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">August 2014</completion_date>
  <primary_completion_date type="Anticipated">August 2014</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the incidence of stroke in a follow-up period</measure>
    <time_frame>one year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>blood pressure during the compliance status in a follow-up</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patients with blood pressure variability in a follow-up</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in intracranial arterial stenosis and stiffness before and after the follow-up</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other vascular events ( acute ischemic heart disease or vascular death )</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Blood Pressure Variability</condition>
  <condition>Intracranial Artery Stenosis</condition>
  <arm_group>
    <arm_group_label>amlodipine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The amlodipine - based antihypertensive treatment group (you can add a diuretic or other )</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ACEI / ARB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ACEI / ARB -based antihypertensive treatment group ( you can add the B - blockers or other)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amlodipine</intervention_name>
    <description>The amlodipine - based antihypertensive treatment group (you can add a diuretic or other )</description>
    <arm_group_label>amlodipine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ACEI / ARB</intervention_name>
    <description>ACEI / ARB -based antihypertensive treatment group ( you can add the B - blockers or other)</description>
    <arm_group_label>ACEI / ARB</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aspirin or Clopidogrel</intervention_name>
    <description>aspirin 100mg / d or Clopidogrel 75mg / d (anti-platelet agents)</description>
    <arm_group_label>ACEI / ARB</arm_group_label>
    <arm_group_label>amlodipine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atorvastatin</intervention_name>
    <description>Atorvastatin 10 - 40mg / d ( statin therapy)</description>
    <arm_group_label>ACEI / ARB</arm_group_label>
    <arm_group_label>amlodipine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age : ≥ 18 years of age , ≤ 75 years old&#xD;
&#xD;
          -  with intracranial artery stenosis in ischemic stroke&#xD;
&#xD;
          -  the diagnosis of ischemic cerebrovascular disease are in line with the diagnostic&#xD;
             criteria developed by the Chinese Medical Association Fourth National Cerebrovascular&#xD;
             Disease Conference&#xD;
&#xD;
          -  the patient admitted to hospital receive at least one examination like cranial MRI +&#xD;
             DWI, MRA and TCD examination, clearly associated with intracranial arterial stenosis&#xD;
&#xD;
          -  MRS score ≤ 3 points&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  vascular , cardiac , and unknown causes or other reasons lead to ischemic stroke&#xD;
&#xD;
          -  associated with significant emotional disorders, cognitive impairment or other mental&#xD;
             disorders can not be partners&#xD;
&#xD;
          -  severe occlusion of Unilateral intracranial arteries ( over 90 % ) or bilateral&#xD;
             stenosis more than 70%&#xD;
&#xD;
          -  With extracranial artery stenosis, especially carotid and vertebral artery stenosis .&#xD;
&#xD;
          -  patients with extracranial artery stenosis or patients previously done neck or&#xD;
             intracranial artery balloon dilation , stent forming surgery or carotid endarterectomy&#xD;
&#xD;
          -  Incomplete clinical data collection in patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guowen Shi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>RenJi Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Guowen Shi, MD</last_name>
    <phone>86-13651932966</phone>
    <email>shigw228@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>RenJi Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200127</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Guowen Shi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 13, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <last_update_submitted>August 14, 2012</last_update_submitted>
  <last_update_submitted_qc>August 14, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 15, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>RenJi Hospital</investigator_affiliation>
    <investigator_full_name>Shi Guowen</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Constriction, Pathologic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspirin</mesh_term>
    <mesh_term>Amlodipine</mesh_term>
    <mesh_term>Clopidogrel</mesh_term>
    <mesh_term>Atorvastatin</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01665235
org study id: RenJiH-20120804
nct id: NCT01665235
lead sponsor: 
has dmc: Yes
Correlation study about Blood Pressure Variability and the prognosis of ischemic stroke with
      intracranial artery stenosis
Extracranial atherosclerotic stenosis is the main reason for the European and American white
      ischemic stroke and transient ischemic attack,while Atherosclerotic intracranial arterial
      stenosis is an important reason for Asian patients with stroke ,accounting for the 33% to 51%
      of a etiology ratio.The latest research suggests that varying degrees of blood pressure
      variability can affect the risk of stroke.This study observe the relationship between blood
      pressure variability and prognosis of ischemic stroke patients with intracranial arterial
      stenosis,with cranial magnetic resonance imaging (MRI + DWI),magnetic resonance angiography
      and Trans-cranial Doppler(TCD) .
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: the incidence of stroke in a follow-up period
time frame: one year
measure: blood pressure during the compliance status in a follow-up
time frame: one year
measure: patients with blood pressure variability in a follow-up
time frame: one year
measure: Changes in intracranial arterial stenosis and stiffness before and after the follow-up
time frame: one year
measure: Other vascular events ( acute ischemic heart disease or vascular death )
time frame: one year
arm group label: amlodipine
arm group type: Active Comparator
description: The amlodipine - based antihypertensive treatment group (you can add a diuretic or other )
arm group label: ACEI / ARB
arm group type: Experimental
description: ACEI / ARB -based antihypertensive treatment group ( you can add the B - blockers or other)
intervention type: Drug
intervention name: Amlodipine
description: The amlodipine - based antihypertensive treatment group (you can add a diuretic or other )
arm group label: amlodipine
intervention type: Drug
intervention name: ACEI / ARB
description: ACEI / ARB -based antihypertensive treatment group ( you can add the B - blockers or other)
arm group label: ACEI / ARB
intervention type: Drug
intervention name: Aspirin or Clopidogrel
description: aspirin 100mg / d or Clopidogrel 75mg / d (anti-platelet agents)
arm group label: ACEI / ARB
arm group label: amlodipine
intervention type: Drug
intervention name: Atorvastatin
description: Atorvastatin 10 - 40mg / d ( statin therapy)
arm group label: ACEI / ARB
arm group label: amlodipine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Guowen Shi, MD
role: Principal Investigator
affiliation: RenJi Hospital
last name: Guowen Shi, MD
phone: 86-13651932966
email: shigw228@126.com
facility: 
status: Recruiting
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: RenJi Hospital
investigator full name: Shi Guowen
investigator title: Principal Investigator
mesh term: Ischemic Stroke
mesh term: Constriction, Pathologic
mesh term: Aspirin
mesh term: Amlodipine
mesh term: Clopidogrel
mesh term: Atorvastatin