This randomized trial tests the effect of early blood pressure reduction on major disability and death among patients with acute ischemic stroke in china.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
4,071
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.
Soohow University
Suzhou, Jiangsu, China
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.
Time frame: 2 weeks
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months
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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.
Time frame: 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).
Time frame: 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.
Time frame: Three months
Quality of Life
Due to limited funding, quality of life data were not collected.
Time frame: 3 months