IndObufen Versus asPirin After Coronary Drug-eluting Stent implantaTION in Elderly Patients With Acute Coronary Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 2,846
- 试验地点
- 1
- 主要终点
- net adverse clinical events (NACEs)
研究概览
简要总结
The OPTION2 trial (randomized controlled trial of IndObufen versus asPirin after coronary drug-eluting stent implantaTION in elderly patients with acute coronary syndrome) was designed to compare the 1-year clinical efficacy and safety of indobufen-based dual antiplatelet therapy (DAPT) (indobufen 100mg bid plus ticagrelor 90mg bid) or conventional DAPT (aspirin 100mg qd plus ticagrelor 90mg bid) in acute coronary syndrome (ACS) patients aged over 65 years old undergoing coronary drug-eluting stent (DES) implantation.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 65 years old
- •Diagnosed with acute coronary syndrome (unstable angina/ non-ST elevation myocardial infarction/ ST elevation myocardial infarction)
- •Treated with at least 1 DES implanted in the coronary lesion
- •Receiving dual antiplatelet therapy (aspirin plus ticagrelor)
- •Agree to attend the trial
排除标准
- •Elective surgical procedure planned within 12 months
- •Life expectancy ≤1 year
- •Known allergy or intolerance to aspirin, ticagrelor or nonsteroidal anti-inflammatory drugs (NSAIDs)
- •History of cerebral hemorrhage
- •History of stroke in six months
- •Active bleeding
- •Known relevant hematological deviations
- •Known, clinically important thrombocytopenia (i.e., <100*10^9/L) or anemia (i.e., <90g/L)
- •Active cancer
- •Concomitant use of oral anticoagulants
- •Active participation in another clinical study
- •Other situations in which the investigator considers unsuitable to attend the study
研究组 & 干预措施
indobufen plus ticagrelor
Patients meeting the criteria are randomized before discharge from the hospital and given indobufen 100 mg bid and ticagrelor 90mg bid the second day after randomization. The administration shall last 12 months.
干预措施: Indobufen (Drug)
indobufen plus ticagrelor
Patients meeting the criteria are randomized before discharge from the hospital and given indobufen 100 mg bid and ticagrelor 90mg bid the second day after randomization. The administration shall last 12 months.
干预措施: Ticagrelor (Drug)
aspirin plus ticagrelor
Patients meeting the criteria are randomized before discharge from the hospital and continued aspirin 100 mg qd and ticagrelor 90mg bid. The administration shall last 12 months.
干预措施: Aspirin (Drug)
aspirin plus ticagrelor
Patients meeting the criteria are randomized before discharge from the hospital and continued aspirin 100 mg qd and ticagrelor 90mg bid. The administration shall last 12 months.
干预措施: Ticagrelor (Drug)
结局指标
主要结局
net adverse clinical events (NACEs)
时间窗: 1-year
including ischemic and bleeding events, i.e., a composite of cardiovascular (CV) death, nonfatal myocardial infarction (MI), ischemic stroke, definite or probable stent thrombosis (ST), or Bleeding Academic Research Consortium (BARC) criteria type 2, 3 or 5 bleeding
次要结局
- BARC criteria type 2, 3 or 5 bleeding events(1-year)
- a composite endpoint of CV death, nonfatal MI, ischemic stroke, definite or probable ST, or BARC criteria type 3 or 5 bleeding(1-year)
- a composite of CV death, nonfatal MI, ischemic stroke, definite or probable ST(1-year)
- all-cause mortality(1-year)
研究者
Junbo Ge
Professor
Shanghai Zhongshan Hospital