Safety and Efficacy of Treatment With Early Low-dose ASpirin Use After Intravenous Thrombolysis for Acute Ischemic Cerebral Infarction (ELASTIC): A Randomized, Open-label, Blinded Endpoint, Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Proportion of Patients with Favorable Functional Outcome at 3 Months
研究概览
简要总结
This study evaluates whether early administration of low-dose aspirin (100mg) at 2 hours post-intravenous thrombolysis, compared to the standard timing of 24 hours, improves functional outcomes in patients with acute ischemic stroke. Intravenous thrombolysis is effective for very early treatment of acute ischemic stroke. However, current guidelines recommend starting antiplatelet therapy 24 hours after thrombolysis to avoid symptomatic intracranial hemorrhage (SICH), a recommendation not based on prospective clinical studies. Early re-occlusion of recanalized arteries due to platelet aggregation occurs in 14-34% of cases and is associated with poor prognosis. The average incidence of SICH is 2.4%, with fatal SICH occurring in only 0.28%. Thus, the impact of re-occlusion on poor prognosis may outweigh the risk of SICH. In this prospective, randomized, open-label trial with blinded endpoint evaluation, participants are assigned to receive aspirin 100mg either at 2 hours (early group) or at 24 hours (standard group) after thrombolysis. The primary outcome is the proportion of patients with a favorable functional outcome, defined as a modified Rankin Scale (mRS) score of 0-2 at 3 months. Safety outcomes include the incidence of SICH and all-cause mortality at 3 months. This study will provide clinical evidence regarding the optimal timing for initiating antiplatelet therapy after thrombolysis in acute ischemic 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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range: 18-65 years old
- •Receive rt PA thrombolytic therapy within 3 hours (including 3 hours) of onset
- •Signs of brain dysfunction lasting for more than 1 hour
- •CT imaging excludes cerebral hemorrhage, and there are no imaging changes corresponding to the patient's physical signs
排除标准
- •Age>65 years old
- •Onset time>3 hours
- •Accompanied by consciousness disorders, or NIHSS ≥ 20 points
- •CT shows' high-density shadow of middle cerebral artery '
- •Accompanied by atrial fibrillation or clearly identified as cardioembolic embolism
- •Severe swallowing difficulties, unable to take medication orally
- •Oral anticoagulant medication is currently being taken
- •Accompanied by severe infection or evidence of severe infection
- •Refusal to sign the informed consent form for this study
- •Exclusion criteria for other traditional intravenous thrombolysis
研究组 & 干预措施
Early Aspirin Group
Participants receive oral aspirin 100mg at 2 hours after rt-PA thrombolysis. A follow-up CT scan is performed at 2 hours post-thrombolysis. If no intracranial hemorrhage is confirmed, aspirin 100mg once daily (Qd) is continued for 3 months.
干预措施: Aspirin (Early, 2h) (Drug)
Standard Therapy Group
Participants receive oral aspirin 100mg once daily (Qd) starting at 24 hours after rt-PA thrombolysis. A follow-up CT scan is performed at 24 hours post-thrombolysis. If no intracranial hemorrhage is confirmed, aspirin 100mg once daily (Qd) is continued for 3 months.
干预措施: Aspirin (Standard, 24h) (Drug)
结局指标
主要结局
Proportion of Patients with Favorable Functional Outcome at 3 Months
时间窗: 3 months
Favorable functional outcome is defined as a score of 0 to 2 on the modified Rankin Scale (mRS). The mRS score will be assessed by a blinded endpoint assessor at 3 months post-stroke via a structured telephone interview or during a clinic visit.
次要结局
- Incidence of symptomatic intracranial hemorrhage(24 hour)
- Patient mortality rate at 3 months(3 months)