A Multinational, Randomised, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Ticagrelor 90 mg twice daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Stroke in Patients with Type 2 Diabetes MellitusTHEMIS: effect of Ticagrelor on Health outcomes in diabEtes Mellitus patients Intervention Study]
试验速览
- 阶段
- Phase 3 4
- 状态
- 进行中（未招募）
- 入组人数
- 17,000
- 试验地点
- 11
- 主要终点
- Time to first event included in the composite endpoint of CV death, MI or ischemic stroke
研究概览
简要总结
This study is a Multicentre, Randomised, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Ticagrelor twice daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Stroke in Patients with Type 2 Diabetes Mellitus. Total duration of the study is up to 3.5 years. Total of 17000 subjects will be randomized globally from approximately 1000 sites from 40 countries. The primary outcome measures will be Time to first event included in the composite endpoint of CV death, MI or ischemic stroke. And secondary outcome measures will be: Time to Prevention of the composite of all-cause death, MI or stroke;, Time to Prevention of CV death , Time to Prevention of all-cause death
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 50.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢ Provision of informed consent prior to any study specific procedures • Female or male aged equal.
- •greater than 50 years old • Diagnosed with Type 2 Diabetes with High Risk for Cardiovascular events with defined as history of percutaneous coronary intervention or coronary artery bypass graft or angiographic evidence of equal.
- •greater than 50% lumen stenosis of at least 1 coronary artery.
排除标准
- •â€¢ Previous MI • Previous Stroke • Known severe liver disease (e.g., ascites and/or clinical signs of coagulopathy) • Women of child-bearing potential (ie, those who are not chemically or surgically sterilised or who are not post-menopause) who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator OR women who have a positive pregnancy test at enrolment or randomisation OR women who are breast-feeding.
结局指标
主要结局
Time to first event included in the composite endpoint of CV death, MI or ischemic stroke
时间窗: Time to first event included in the composite endpoint of CV death, MI or ischemic stroke
次要结局
- Time to Prevention of the composite of all-cause death, MI or stroke. Time to Prevention of CV death Time to Prevention of all-cause death