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临床试验/NCT06053021
NCT06053021招募中不适用

Antiplatelet Therapy for Acute Ischemic Stroke Patients With Thrombocytopenia

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2023年9月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,200
试验地点
1
主要终点
90-day Composite events

研究概览

简要总结

The goal of this clinical trial is to test the safety and effectiveness of antiplatelet therapy in acute ischemic stroke (AIS) patients with thrombocytopenia. Participants will be prescribed antiplatelet agents and followed up for 3 months.

详细描述

Antiplatelet therapy is widely used in non-cardiogenic AIS patients for secondary prevention. However, it may also increase the risk of bleeding complications, especially in patients with thrombocytopenia. The goal of this clinical trial is to test the safety and effectiveness of antiplatelet therapy in acute ischemic stroke (AIS) patients with thrombocytopenia. Participants will be prescribed antiplatelet agents and followed up for 3 months.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 18 years old
  • Acute ischemic stroke or transient ischemic attack with onset < 7 days
  • The last blood routine test before enrollment indicates platelet count < 100 x 10^9 and > 30 x 10^9

排除标准

  • Chronic renal dysfunction (GFR < 30ml/min) or severe hepatic injury
  • Indications for anticoagulation therapy, e.g. atrial fibrillation
  • Myocardial infarction within 6 months before enrollment or received percutaneous coronary intervention in the past
  • Have or plan to receive CEA or CAS in the following 3 months
  • Life expectancy less than 1 year
  • Plan to receive invasive surgery in the following 3 months and have high risk of uncontrollable bleeding
  • Pregnant or lactating women
  • Individuals identified by researchers as unsuitable for participation in the study due to other reasons.

研究组 & 干预措施

Intervention

Experimental

Participants will be prescribed antiplatelet agents including aspirin, clopidogrel, cilostazol, and dipyridamole.

干预措施: aspirin, clopidogrel, cilostazol, and dipyridamole (Drug)

结局指标

主要结局

90-day Composite events

时间窗: 90 days

Composite events including ischemic stroke, hemorrhagic stroke, myocardial infarction, major extracranial hemorrhage, and vascular death within 90 days after enrollment

次要结局

  • 90-day myocardial infarction(90 days)
  • 90-day non-major bleeding(90 days)
  • 90-day ischemic stroke(90 days)
  • 90-day all-cause death(90 days)
  • 90-day hemorrhagic stroke(90 days)
  • 90-day major extracranial hemorrhage(90 days)
  • 90-day vascular death(90 days)
  • Discharge mRS(Through hospitalization, an average of 7 days)

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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