Randomized Comparison of Short Versus 12 Months Prasugrel Plus Aspirin in Patients with Acute Coronary Syndromes Treated with Percutaneous Coronary Intervention and Everolimus-eluting Stents (SORT OUT XII DAPT Duration Trial)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 3,150
- 试验地点
- 3
- 主要终点
- Number of patients with clinically relevant bleeding (Effectiveness)
研究概览
简要总结
The SORT OUT XII dual antiplatelet treatment (DAPT) duration trial, is a clinical randomized controlled superiority and non-inferiority trial to compare whether prasugrel alone versus prasugrel plus aspirin from month 1 to month 12 after percutaneous coronary intervention with and everolimus-eluting stent in patients with acute coronary syndromes (1) is superior regarding clinically relevant bleeding and (2) non-inferior regarding safety (cardiac death, myocardial infarction, definite stent thrombosis, ischemic stroke or clinically driven target lesion revascularization)
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients aged ≥18 years with acute coronary syndromes who are treated with an everolimus-eluting drug-eluting stent can undergo randomization if they can be treated with prasugrel for 12 months.
- •Postmenopausal women or use of contraceptive drugs (absence of menstruation in at least 12 consecutive months or continuously usage of contraceptive drugs (a contraceptive implant, an intrauterine device, birth-control pills, transdermal patches, vaginal ring, or depot injection).
排除标准
- •Age < 18 years
- •Not able to consent to study participating (eg. intubated patients)
- •Do not speak Danish
- •Life expectancy <1 year
- •Allergic to study related treatment
- •Non-vitamin K antagonist oral anticoagulants (NOAC) or warfarin treatment
- •Contraindication for 12 months prasugrel treatment
研究组 & 干预措施
Short duration of DAPT
干预措施: Short duration of aspirin and prasugrel (Drug)
Conventional duration of DAPT
干预措施: Conventional duration of aspirin and prasugrel (Drug)
结局指标
主要结局
Number of patients with clinically relevant bleeding (Effectiveness)
时间窗: 1 year
Clinically relevant bleeding is defined a "Bleeding Academic Research Consortium" (BARC) where BARC group 2, 3 and 5 are registered
Number of patients with a composite major adverse cardiovascular or cerebrovascular events (Safety)
时间窗: 1 year
Major adverse cardiovascular or cerebrovascular events (MACCE) is defined as a composite of cardiac death, myocardial infarction, definite stent thrombosis, ischemic stroke or clinically driven target lesion revascularization)
次要结局
- Number of patients with clinically relevant bleeding(1 year)
- Number of patients with all-cause death(1 year)
- Number of patients with cardiac death(1 year)
- Number of patients with myocardial infarction(1 year)
- Number of patients with definite stent thrombosis(1 year)
- Number of patients with target lesion revascularization(1 year)
- Number of patients with stroke(1 year)
- Health-related quality of life(1 month and 1 year)
- Angina status(1 month and 1 year)