NCT00979589已完成3 期
Randomized,Double-blind Trial Comparing the Effects of a 3-month Clopidogrel Regimen,Combined With ASA During the First 21days,Versus ASA Alone for the Acute Treatment of TIA or Minor Stroke
Beijing Tiantan Hospital1 个研究点 分布在 1 个国家目标入组 5,100 人开始时间: 2009年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5,100
- 试验地点
- 1
- 主要终点
- Percentage of patients with the 3-month new vascular events, defined as any event of the following: Any stroke (ischemic or hemorrhage)
研究概览
简要总结
The purpose of this study is to assess the effects of a 3-month regimen of clopidogrel initiated with a loading dose (LD) of 300 mg followed by 75 mg/day during the first 21days versus a 3-month regimen of ASA 75 mg/day alone on reducing the 3-month risk of any stroke (both ischemic and hemorrhagic, primary outcome) when initiated within 24 hours of symptom onset in high-risk patients with TIA or minor stroke.
详细描述
Inclusion criteria:
- Adult subjects (male or female ≥ 40 years)
- Acute non-disabling ischemic stroke (NIHSS≤3 at the time of randomization) that can be treated with study drug within 24 hours of symptoms onset. Symptom onset is defined by the "last see normal" principle.
- TIA (Neurological deficit attributed to focal brain ischemia, with resolution of the deficit within 24 hours of symptom onset), that can be treated with study drug within 24 hours of symptoms onset and with moderate-to-high risk of stroke recurrence (ABCD2 score ≥ 4 at the time of randomization). Symptom onset is defined by the "last see normal" principle.
- Informed consent signed
Primary Efficacy Endpoint:
Percentage of patients with the 3-month new vascular events, defined as any event of the following:Any stroke (ischemic or hemorrhage).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Diagnosis of hemorrhage or other pathology, such as vascular malformation, tumor, abscess or other major non-ischemic brain disease (e.g., multiple sclerosis) on baseline head CT or MRI
- •Isolated or pure sensory symptoms (e.g., numbness), isolated visual changes, or isolated dizziness/vertigo without evidence of acute infarction on baseline head CT or MRI
- •Modified Rankin Scale Score>2 at randomization (pre-morbid historical assessment)
- •NIH Stroke Score≥4 at randomization
- •Clear indication for anticoagulation(presumed cardiac source of embolus, e.g., atrial fibrillation, prosthetic cardiac valves known or suspected endocarditis)
- •Contraindication to clopidogrel or ASA
- •Known allergy
- •Severe renal or hepatic insufficiency
- •Severe cardiac failure, asthma
- •Hemostatic disorder or systemic bleeding
- •History of hemostatic disorder or systemic bleeding
- •History of thrombocytopenia or neutropenia
- •History of drug-induced hematologic or hepatic abnormalities
- •Low white blood cell (<2 x109/l) or platelet count (<100 x109/l)
- •Use of thrombolysis within 24 hours prior to randomization
- •History of intracranial hemorrhage
- •Anticipated requirement for long-term non-study antiplatelet drugs, or NSAIDs affecting platelet function
- •Current treatment (last dose given within 10 days before randomization) with heparin therapy or oral anti coagulation
- •Gastrointestinal bleed or major surgery within 3 months
- •Planned or likely revascularization (any angioplasty or vascular surgery) within the next 3 months (if clinically indicated, vascular imaging should be performed prior to randomization whenever possible)
- •Scheduled for surgery or interventional treatment requiring study drug cessation
- •Qualifying TIA or minor stroke induced by angiography or surgery
- •Severe non-cardiovascular comorbidity with life expectancy < 3 months
- •Women of childbearing age not practicing reliable contraception who do not have a documented negative pregnancy test
- •Currently receiving an investigational drug or device
研究组 & 干预措施
Combination Clopidogrel and asprin
Active Comparator
干预措施: Clopidogrel (Drug)
Asprin and placebo
Placebo Comparator
干预措施: Placebo of clopidogrel and Asprin (Drug)
结局指标
主要结局
Percentage of patients with the 3-month new vascular events, defined as any event of the following: Any stroke (ischemic or hemorrhage)
时间窗: 3 months
次要结局
- Further efficacy exploratory analysis:Quality of Life (EuroQol EQ-5D scale)(3 months)
- Further efficacy exploratory analysis:Impairment (changes in NIHSS scores at 3 month follow-up).(3 months)
- Percentage of patients with the 3-month new clinical vascular events (ischemic stroke/ hemorrhagic stroke/ TIA/ MI/ vascular death) as a cluster and evaluated individually.(3 months)
- Modified Rankin Scale score changes (continuous) and dichotomized at percentage with score 0-2 vs. 3-6 at 3 month follow-up(3 months)
- Efficacy endpoint will also be analyzed stratified by etiological subtypes, by time randomization (< 12 hours vs. ≥ 12 hours), by qualifying event (TIA vs. minor stroke), and by age(3 months)
- Severe bleeding incidence (GUSTO definition), including fatal bleeding and symptomatic intracranial hemorrhage.(3 months)
- Incidence symptomatic and asymptomatic intracranial hemorrhagic events at 3 months(3 months)
- Intracranial hemorrhage(3 months)
- Total mortality(3 months)
研究者
Yongjun Wang
Executive Vice-President
Beijing Tiantan Hospital
研究点 (1)
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