China Antihypertensive Trial in Acute Ischemic Stroke "CATIS"

Active, not recruiting

Phase N/A Results

Trial 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

Conditions

Interventions

  • Active antihypertensive treatment Other
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Active antihypertensive treatment
    Description: Active antihypertensive treatment

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary A combined outcome of in-hospital case-fatality rate (within 2-weeks) and dependency (modified Rankin scale >2) 2 weeks Yes
Primary Neurological dysfunction (NIH Stroke Scale, NIHSS) 2 weeks Yes
Secondary Mortality 3, 12, and 24 months No
Secondary Recurrent stroke 3, 12 and 24 months No
Secondary Other vascular events 3, 12 and 24 months No
Secondary Long-term neurological and functional status 3, 12 and 24 months No
Secondary Cognitive function 3, 12 and 24 months No
Secondary Quality of life 3, 12 and 24 months No
Primary 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. 2 weeks Yes

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