Early Antiplatelet for Minor Stroke Following Thrombolysis (EAST): a Prospective, Random, Double Blinded and Multi-center Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,022
- 试验地点
- 2
- 主要终点
- The proportion of excellent prognosis
研究概览
简要总结
The current guideline recommends to give antithrombotic treatment 24 hours after intravenous thrombolysis in acute ischemic stroke. However, early neurological deterioration will occur in some patients due to no antithrombotic treatment, which is closely associated with poor outcome. The current trial aims to investigate the effectiveness and safety of early antithrombotic treatment after intravenous thrombolysis in minor stroke.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old;
- •Acute ischemic stroke patients who received intravenous thrombolysis within 4.5 hours of onset;
- •NIHSS ≤ 5 within 6 hours after the end of intravenous thrombolysis, and no bleeding transformation was found in head CT examination;
- •Premorbid mRS ≤ 1;
- •Signed informed consent.
排除标准
- •Premorbid mRS≥2;
- •Uncontrolled severe hypertension (systolic pressure >180 mmHg or diastolic pressure >110 mmHg after drug treatment);
- •Antithrombotic treatment within 24 hours before randomization;
- •Significant dysphagia and inability to take the experimental drug orally;
- •Allergy or contraindication to study drugs;
- •Comorbidity with any serious diseases and life expectancy is less than half a year;
- •Participating in other clinical trials within three months;
- •Patients not suitable for this clinical study considered by researcher
研究组 & 干预措施
double antiplatelet group
aspirin 100mg plus clopidogrel 300mg
干预措施: Aspirin 100mg; Clopidogrel 300mg (Drug)
control group
aspirin placebo plus clopidogrel placebo
干预措施: Aspirin 100mg; Clopidogrel 300mg (Drug)
结局指标
主要结局
The proportion of excellent prognosis
时间窗: Day 90
excellent prognosis is defined as modified Rankin Score (mRS) 0-1. The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
次要结局
- The death due to any cause(Day 90)
- The proportion of favorable prognosis(Day 90)
- Distribution of modified Rankin Score (mRS)(Day 90)
- Changes in National Institute of Health stroke scale (NIHSS)(24 hours, 48 hours, and 10 days)
- Occurrence of early neurologyical deterioration (END)(24 hours)
- The incidence of any intracerebral hemorrhage(36 hours)
- The incidence of stroke recurrence and other vascular events(Day 90)
- The incidence of symptomatic intracerebral hemorrhage(36 hours)
研究者
Hui-Sheng Chen
Head of Neurology
General Hospital of Shenyang Military Region