China Antihypertensive Trial in Acute Ischemic Stroke

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Other: Active antihypertensive treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active antihypertensive treatment<br>Active antihypertensive treatment | Other: Active antihypertensive treatment<br>* 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.<br>|
| No Intervention: Usual care<br>Discontinue all home BP medications. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A Combination of Death Within 14 Days After Randomization and Major Disability at 14 Days or at Hospital Discharge if Earlier Than 14 Days. | 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. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A Combination of All-cause Mortality and Major Disability at the 3-month Post-treatment Follow-up. | 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 | 3 months | 
| Mortality | 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. | 3 months | 
| Recurrent Stroke | 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. | 3 months | 
| Other Vascular Events | 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. | 3 months | 
| Long-term Neurological and Functional Status | 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. | Three months | 
| Cognitive Function (the Mini-Mental State Examination) | 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). | Three months | 
| Cognitive Function (Montreal Cognitive Assessment) | 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. | Three months | 
| Quality of Life | Due to limited funding, quality of life data were not collected. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ischemic stroke, Hypertension, Antihypertensive Agents, Randomized Controlled Trial