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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,071
- 试验地点
- 1
- 主要终点
- A Combination of Death Within 14 Days After Randomization and Major Disability at 14 Days or at Hospital Discharge if Earlier Than 14 Days.
研究概览
简要总结
This randomized trial tests the effect of early blood pressure reduction on major disability and death among patients with acute ischemic stroke in china.
详细描述
We designed a randomized controlled clinical trial to test:
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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.
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The effectiveness of blood pressure reduction among patients with acute ischemic stroke (within 48-hours of onset) on secondary outcomes:
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Combination of all-cause mortality and dependency over 3, 12, and 24 months of follow-up
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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)
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Recurrent fatal and non-fatal stroke over 3, 12, and 24 months of follow-up
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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
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All-cause mortality over 3, 12, and 24 months of follow-up
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Duration of initial hospitalization
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Changes in systolic and diastolic blood pressure within 24 hours and over 7 days, and 14 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Active antihypertensive treatment
Active antihypertensive treatment
干预措施: Active antihypertensive treatment (Other)
Usual care
Discontinue all home BP medications.
结局指标
主要结局
A Combination of Death Within 14 Days After Randomization and Major Disability at 14 Days or at Hospital Discharge if Earlier Than 14 Days.
时间窗: 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.
次要结局
- Cognitive Function (the Mini-Mental State Examination)(Three months)
- Quality of Life(3 months)
- Long-term Neurological and Functional Status(Three months)
- Other Vascular Events(3 months)
- A Combination of All-cause Mortality and Major Disability at the 3-month Post-treatment Follow-up.(3 months)
- Mortality(3 months)
- Recurrent Stroke(3 months)
- Cognitive Function (Montreal Cognitive Assessment)(Three months)
研究者
Jiang He, MD, PhD
Professor and Department Chair
Tulane University