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China Antihypertensive Trial in Acute Ischemic Stroke (CATIS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01840072
First Posted: April 25, 2013
Last Update Posted: April 25, 2017
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.
Collaborator:
Soochow University
Information provided by (Responsible Party):
Jiang He, MD, PhD, Tulane University
  Purpose
This randomized trial tests the effect of early blood pressure reduction on major disability and death among patients with acute ischemic stroke in china.

Condition Intervention
Ischemic Stroke Other: Active antihypertensive treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Jiang He, MD, PhD, Tulane University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 4071
Study Start Date: August 2009
Study Completion Date: May 2016
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active antihypertensive treatment
Active antihypertensive treatment
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.
No Intervention: Usual care
Discontinue all home BP medications.

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840072


Locations
China, Jiangsu
Soohow University
Suzhou, Jiangsu, China, 215123
Sponsors and Collaborators
Tulane University
Soochow University
Investigators
Principal Investigator: Jiang He, MD, PhD Tulane University SPHTM
  More Information

Publications:
Responsible Party: Jiang He, MD, PhD, Professor and Department Chair, Tulane University
ClinicalTrials.gov Identifier: NCT01840072     History of Changes
Other Study ID Numbers: 140815
First Submitted: April 13, 2013
First Posted: April 25, 2013
Results First Submitted: November 13, 2014
Results First Posted: November 20, 2014
Last Update Posted: April 25, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jiang He, MD, PhD, Tulane University:
Ischemic stroke
Hypertension
Antihypertensive Agents
Randomized Controlled Trial

Additional relevant MeSH terms:
Stroke
Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action