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China Antihypertensive Trial in Acute Ischemic Stroke (CATIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01840072
Recruitment Status : Completed
First Posted : April 25, 2013
Results First Posted : November 20, 2014
Last Update Posted : April 25, 2017
Sponsor:
Collaborator:
Soochow University
Information provided by (Responsible Party):
Jiang He, MD, PhD, Tulane University

Tracking Information
First Submitted Date  ICMJE April 13, 2013
First Posted Date  ICMJE April 25, 2013
Results First Submitted Date  ICMJE November 13, 2014
Results First Posted Date  ICMJE November 20, 2014
Last Update Posted Date April 25, 2017
Study Start Date  ICMJE August 2009
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2017)
A Combination of Death Within 14 Days After Randomization and Major Disability at 14 Days or at Hospital Discharge if Earlier Than 14 Days. [ Time Frame: 2 weeks ]
Major disability was defined as a score of 3 to 5 on the modified Rankin Scale at 14 days after randomization. Scores on the modified Rankin Scale range from 0 to 6, with a score of 0 indicating no symptoms; a score of 5 indicating severe disability (ie, bedridden, incontinent, or requiring constant nursing care and attention); and a score of 6 indicating death.
Original Primary Outcome Measures  ICMJE
 (submitted: April 22, 2013)
  • A combined outcome of in-hospital case-fatality rate (within 2-weeks) and dependency (modified Rankin scale >2) [ Time Frame: 2 weeks ]
    The assessment using the modified Rankin scale will be obtained on 14 day after the randomization or at the hospital discharge.
  • Neurological Dysfunction (NIH Stroke Scale, NIHSS) [ Time Frame: 2 weeks ]
    Neurological dysfunction assessment using NIHSS will be obtained on 14 day after the randomization or at the hospital discharge.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2017)
  • A Combination of All-cause Mortality and Major Disability at the 3-month Post-treatment Follow-up. [ Time Frame: 3 months ]
    Major disability was defined as a score of 3 to 5 on the modified Rankin Scale at 3 months after randomization. Scores on the modified Rankin Scale range from 0 to 6, with a score of 0 indicating no symptoms; a score of 5 indicating severe disability (ie, bedridden, incontinent, or requiring constant nursing care and attention); and a score of 6 indicating death
  • Mortality [ Time Frame: 3 months ]
    Those patients who are still alive at hospital discharge will be contacted by telephone to set up a follow-up clinical visit. Information on clinical deaths will be obtained.
  • Recurrent Stroke [ Time Frame: 3 months ]
    Those patients who are still alive at hospital discharge will be contacted by telephone to set up a follow-up clinical visit. Information of recurrent stroke will be collected.
  • Other Vascular Events [ Time Frame: 3 months ]
    Those patients who are still alive at hospital discharge will be contacted by telephone to set up a follow-up clinical visit. Information of vascular events, such as myocardial infarction, will be collected.
  • Long-term Neurological and Functional Status [ Time Frame: Three months ]
    Those patients who were still alive at hospital discharge were contacted by telephone to set up a follow-up clinical visit. Neurological function was assessed by the modified Rankin scale at the 3-month post-treatment follow-up visit. Scores on the modified Rankin Scale range from 0 to 6, with a score of 0 indicating no symptoms; a score of 5 indicating severe disability (ie, bedridden, incontinent, or requiring constant nursing care and attention); and a score of 6 indicating death. Major disability was defined as a score of 3 to 5 on the modified Rankin Scale.
  • Cognitive Function (the Mini-Mental State Examination) [ Time Frame: Three months ]
    Cognitive function was measured by the Mini-Mental State Examination at 3 months after randomization. The MMSE contains 20 items that test cognitive performance in domains including orientation, registration, attention and calculation, recall, language, and visual construction. MMSE scores were divided into three ordinal categories: 24-30 (no cognitive impairment), 19-23 (mild cognitive impairment), and 0-17 (severe cognitive impairment).
  • Cognitive Function (Montreal Cognitive Assessment) [ Time Frame: Three months ]
    Cognitive function was measured by Montreal Cognitive Assessment at 3 months after randomization. The MoCA is a 30-item test that evaluates the following seven cognitive domains: visuospatial/executive functions, naming, memory, attention, language, abstraction, and orientation. One point is added for participants with education <12 years. Scores on the MoCA range from 0 to 30 and cognitive impairment was defined as a score of <26.
  • Quality of Life [ Time Frame: 3 months ]
    Due to limited funding, quality of life data were not collected.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2013)
  • Mortality [ Time Frame: 3, 12, and 24 months ]
    Those patients who are still alive at hospital discharge will be contacted by telephone to set up a follow-up clinical visit. Information on clinical deaths will be obtained.
  • Recurrent Stroke [ Time Frame: 3, 12 and 24 months ]
    Those patients who are still alive at hospital discharge will be contacted by telephone to set up a follow-up clinical visit. Information of recurrent stroke will be collected.
  • Other Vascular Events [ Time Frame: 3, 12 and 24 months ]
    Those patients who are still alive at hospital discharge will be contacted by telephone to set up a follow-up clinical visit. Information of vascular events, such as myocardial infarction, will be collected.
  • Long-term Neurological and Functional Status [ Time Frame: 3, 12 and 24 months ]
    Those patients who are still alive at hospital discharge will be contacted by telephone to set up a follow-up clinical visit. Neurological and functional assessments including the modified Rankin scale and NIHSS will be performed.
  • Cognitive Function [ Time Frame: 3, 12 and 24 months ]
    Those patients who are still alive at hospital discharge will be contacted by telephone to set up a follow-up clinical visit. The information on the cognitive function will be obtained.
  • Quality of Life [ Time Frame: 3, 12 and 24 months ]
    Those patients who are still alive at hospital discharge will be contacted by telephone to set up a follow-up clinical visit. The information on the quality of life will be obtained.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE China Antihypertensive Trial in Acute Ischemic Stroke
Official Title  ICMJE Inner Mongolia Stroke Project A Randomized Controlled Trial of Immediate Blood Pressure Reduction on Death and Major Disability in Patients With Acute Ischemic Stroke in China
Brief Summary This randomized trial tests the effect of early blood pressure reduction on major disability and death among patients with acute ischemic stroke in china.
Detailed Description

We designed a randomized controlled clinical trial to test:

  • The effectiveness of blood pressure reduction among patients with acute ischemic stroke (within 48 hours of onset) on the primary outcome, a combination of death within 14 days after randomization and dependency (modified Rankin scale ≥3) at 14 day or at the time of discharge, if that occurred before 14 days.
  • The effectiveness of blood pressure reduction among patients with acute ischemic stroke (within 48-hours of onset) on secondary outcomes:

    • Combination of all-cause mortality and dependency over 3, 12, and 24 months of follow-up
    • Combined vascular disease events over 3, 12, and 24 months of follow-up (vascular deaths, non-fatal stroke, non-fatal myocardial infarction, coronary revascularization, hospitalized or treated angina, hospitalized or treated congestive heart failure, and hospitalized or treated peripheral arterial disease)
    • Recurrent fatal and non-fatal stroke over 3, 12, and 24 months of follow-up
    • Neurological functional status measured by NIH Stroke Score and modified Rankin scale at 14 day or discharge after randomization, and over 3, 12, and 24 months of follow-up
    • All-cause mortality over 3, 12, and 24 months of follow-up
    • Duration of initial hospitalization
    • Changes in systolic and diastolic blood pressure within 24 hours and over 7 days, and 14 days
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ischemic Stroke
Intervention  ICMJE Other: Active antihypertensive treatment
Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization.
Study Arms  ICMJE
  • Experimental: Active antihypertensive treatment
    Active antihypertensive treatment
    Intervention: Other: Active antihypertensive treatment
  • No Intervention: Usual care
    Discontinue all home BP medications.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 12, 2013)
4071
Original Estimated Enrollment  ICMJE
 (submitted: April 22, 2013)
4000
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥22 years
  • Ischemic stroke onset within 48 hours confirmed by imaging (CT scan or MRI) study
  • Systolic BP≥140 and <220 mm Hg and diastolic BP≥80 mm Hg
  • No contraindications to antihypertensive treatment
  • Able and willing to sign informed consent by patients or their direct family members

Exclusion Criteria:

  • Individuals with hemorrhagic stroke
  • Individuals with severe heart failure (NY Heart Association class III and IV), myocardial infarction, unstable angina, aortic dissection and cerebrovascular stenosis
  • Individuals in a deep coma
  • Individuals with resistant hypertension [systolic BP ≥170 mm Hg despite use of 4 or more antihypertensive medications for half a year or longer]
  • Intravenous thrombolytic therapy (such as intravenous rtPA)
  • Individuals who are unable to participate in follow-up examination
  • Current pregnant women
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01840072
Other Study ID Numbers  ICMJE 140815
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jiang He, MD, PhD, Tulane University
Study Sponsor  ICMJE Tulane University
Collaborators  ICMJE Soochow University
Investigators  ICMJE
Principal Investigator: Jiang He, MD, PhD Tulane University SPHTM
PRS Account Tulane University
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP