跳至主要内容
临床试验/NCT04962451
NCT04962451已完成4 期

Efficacy and Safety of Ticagrelor Combined With ASA Versus ASA Alone in Preventing Stroke and Death in Patients With Acute Ischemic Stroke or Transient Ischemic Attack: a Randomized, Double-blind, Placebo-controlled, International Multicenter Phase III Clinical Study

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 13,000 人开始时间: 2017年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
13,000
试验地点
1
主要终点
Occurrence of adverse events

研究概览

简要总结

Cerebrovascular disease is the main cause of death and severe long-term disability worldwide. Antiplatelet drugs are the main drugs for ischemic stroke and TIA. Cyclooxygenase inhibitor acetylsalicylic acid (ASA) has always been the most widely studied antiplatelet therapy. The studies of acrates of aliscon body evaluated the efficacy and safety of ticagrelor monotherapy in preventing major vascular events in patients with AIS or TIA. The results showed that the number of patients with endpoint events in ticagrelor group was less than that in ASA group, However, it has not been proved that ticagrelor monotherapy is better than ASA. The purpose of this study is to prove that ticagrelor is better than ASA.

详细描述

Cerebrovascular disease is the main cause of death and severe long-term disability worldwide. Antiplatelet drugs are the main drugs for ischemic stroke and TIA. Cyclooxygenase inhibitor acetylsalicylic acid (ASA) has always been the most widely studied antiplatelet therapy. The studies of acrates of aliscon body evaluated the efficacy and safety of ticagrelor monotherapy in preventing major vascular events in patients with AIS or TIA. The results showed that the number of patients with endpoint events in ticagrelor group was less than that in ASA group, However, it has not been proved that ticagrelor monotherapy is better than ASA. The purpose of this study is to prove that ticagrelor is better than ASA. The study will be designed as a randomized, double-blind, placebo-controlled, parallel grouping study and conducted in multiple centers to ensure the representation of multiple countries, races and races, so as to ensure that the results of the study can be widely applied.

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, Investigator)

入排标准

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

入选标准

  • Over 40 years old
  • Acute ischemic attack
  • Symptoms occurred within 24 hours after randomization

排除标准

  • Dual antiplatelet therapy with ASA and P2Y12 inhibitors is needed
  • Antiplatelet agents other than ASA
  • Anticoagulant therapy
  • Have any atrial fibrillation / flutter
  • Renal failure requiring dialysis
  • During pregnancy or lactation

研究组 & 干预措施

Intervention group

Experimental

干预措施: ticagrelor + ASA (Drug)

Placebo group

Placebo Comparator

干预措施: Placebo+ASA (Drug)

结局指标

主要结局

Occurrence of adverse events

时间窗: At day 60 after participants included into the research

The event that patients have stroke or die

次要结局

  • Tool assessment result(At day 60 after participants included into the research)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验