Escalated single Platelet Inhibition for one month plus Direct oral anticoagulation in patients with Atrial fibrillation and acUte coRonary syndrome undergoing percutaneoUS coronary intervention (EPIDAURUS)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,474
- 试验地点
- 21
- 主要终点
- Primary efficacy endpoint: Major ischaemic events defined as the composite of all-cause mortality, myocardial infarction, definite or probable stent thrombosis, ischaemic stroke or systemic thromboembolism (superiority test) at 6 weeks after randomization
研究概览
简要总结
The primary study objective is to test whether an escalated antiplatelet therapy with a potent P2Y12-inhibitor (Prasugrel or Ticagrelor) for 4 weeks can reduce ischaemic events without a significant increase in bleeding complications in patients with atrial fibrillation and ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation acute coronary myocardial infarction (NSTEMI (biomarker -positive acute coronary syndrome) undergoing PCI.
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
- •Written informed consent
- •Age ≥ 18 years
- •Atrial fibrillation requiring oral anticoagulation
- •STEMI or NSTEMI (biomarker positive acute coronary syndrome)
- •Successful completion of PCI (defined as TIMI flow grade 2 or more; randomization will take place within 5 days (recommended within 24h) after successful PCI and before hospital discharge)
排除标准
- •Chronic renal insufficiency with glomerular filtration rate < 15 ml/min/1.73m2
- •Inability to cooperate with the protocol requirements
- •Life expectancy < 6 months
- •Participation in another investigational drug study
- •Previous enrolment in this study
- •For women of childbearing potential no negative pregnancy test and no agree to use a reliable method of birth control during the study
- •Previous treatment with GP IIb/IIIa inhibitors within the last 12 hours
- •A known genetic disorder involved in the metabolism of the study medication
- •Any other reason in the opinion of the investigator making the patient ineligible for participation in the trial
- •History of ischaemic stroke or transient ischaemic attack (both contraindications for Prasugrel) and history of intracranial bleeding (contraindication for Ticagrelor)
- •Contraindication for Clopidogrel or Aspirin
- •Contraindication for Prasugrel and Ticagrelor
- •Severe chronic liver disease (Child-Pugh C)
- •Indication for oral anticoagulation with Vitamin K antagonists
- •Moderate to severe mitral stenosis or mechanical heart valve
- •Any bleeding BARC type ≥ 2 within the last 4 weeks before index procedure
- •Pregnancy or lactation
结局指标
主要结局
Primary efficacy endpoint: Major ischaemic events defined as the composite of all-cause mortality, myocardial infarction, definite or probable stent thrombosis, ischaemic stroke or systemic thromboembolism (superiority test) at 6 weeks after randomization
Primary efficacy endpoint: Major ischaemic events defined as the composite of all-cause mortality, myocardial infarction, definite or probable stent thrombosis, ischaemic stroke or systemic thromboembolism (superiority test) at 6 weeks after randomization
Primarys safety endpoint: Bleeding type 2 or higher according to the Bleeding Academic Research Consortium (BARC) criteria (non-inferiority test) at 6 weeks after randomization
Primarys safety endpoint: Bleeding type 2 or higher according to the Bleeding Academic Research Consortium (BARC) criteria (non-inferiority test) at 6 weeks after randomization
次要结局
- All individual components of the primary endpoint (all-cause mortality, myocardial infarction, definite or probable stent thrombosis, ischaemic stroke, systemic thromboembolism) at 6 weeks after randomization
- Cardiovascular mortality at 6 weeks after randomization
- Bleeding (BARC type ≥ 2) at 6 weeks after randomization
- Urgent revascularization at 6 weeks after randomization
- All-cause mortality at 6 months after randomization
- Unplanned hospitalization due to acute heart failure or acute coronary syndrome at 6 months after randomization
- Ischaemic stroke at 6 months after randomization
研究者
Sponsor delegated person
Scientific
Klinikum der Universitaet Muenchen AöR