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
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
- 否
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
干预措施: ticagrelor + ASA (Drug)
Placebo group
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)
