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
试验速览
- 阶段
- 4 期
- 状态
- 暂停
- 入组人数
- 3,150
- 试验地点
- 3
- 主要终点
- Assessed between 1 and 12 months after PCI Effectiveness: Clinically relevant bleeding (BARC 2, 3 and 5 ). Powered for superiority
研究概览
简要总结
To compare short term antiplatelet therapy to guideline dual antiplatelet therapy duration in patients with acute coronary syndromes treated with an everolimus-eluting stent for bleeding and major adverse cardiovascular or cerebrovascular events
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 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.
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
- •NOAC or warfarin treatment
- •Contraindication for 12 months prasugrel treatment
- •Prior stroke
- •Women of childbearing age, may participate in this study only if you are surgically
结局指标
主要结局
Assessed between 1 and 12 months after PCI Effectiveness: Clinically relevant bleeding (BARC 2, 3 and 5 ). Powered for superiority
Assessed between 1 and 12 months after PCI Effectiveness: Clinically relevant bleeding (BARC 2, 3 and 5 ). Powered for superiority
Assessed between 1 and 12 months after PCI Safety: Composite major adverse cardiovascular or cerebrovascular events (MACCE) (a composite of cardiac death, myocardial infarction, definite stent thrombosis, ischemic stroke or clinically driven target lesion revascularization). Powered for non-inferiority.
Assessed between 1 and 12 months after PCI Safety: Composite major adverse cardiovascular or cerebrovascular events (MACCE) (a composite of cardiac death, myocardial infarction, definite stent thrombosis, ischemic stroke or clinically driven target lesion revascularization). Powered for non-inferiority.
次要结局
- Individual components of the primary end point comprised the secondary end points
- Stent thrombosis rate according to the Academic Research Consortium-2 definition
- Major bleeding (BARC type 2, 3 and 5)
- Health-related quality of life
- Angina status based on the Canadian Cardiovascular Society classification system
研究者
Lisette Okkels Jensen
Scientific
Odense University Hospital