Prasugrel Monotherapy Reduced Dose in Acute and Chronic Coronary Syndrome Patients After Percutaneous Coronary Intervention
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- NACE (Net Adverse Clinical Events)
研究概览
简要总结
Rationale: Dual antiplatelet therapy, consisting of aspirin and a P2Y12-inhibitor, reduces the risk of stent-related and non-stent-related ischemic events after percutaneous coronary intervention (PCI). However, this therapy is also associated with a higher risk of bleeding. Given the advances in stent technology and pharmacology, it may be possible to treat patients undergoing PCI with low dose prasugrel as single antiplatelet therapy, regardless of medical history, age or body weight.
Objective: Assess the feasibility and safety of a single antiplatelet strategy with a reduced dose of prasugrel 5 mg after PCI in acute and chronic coronary syndrome patients (ACS and CCS).
Study design: Open-label, single-centre, randomized controlled trial.
Study population: Patients undergoing successful PCI due to acute or chronic coronary syndrome.
Intervention: A once-daily reduced dose of 5 mg prasugrel for 6 months in CCS patients and for 12 months in ACS patients, preceded by a loading dose of 60 mg prasugrel after PCI, administered without concomitant use of aspirin.
Main study parameters/endpoints: The primary endpoint is Net Adverse Clinical Events (NACE), a composite of all-cause death, myocardial infarction, definite stent thrombosis, ischemic stroke, clinically relevant non-major bleeding or major bleeding defined as Bleeding Academic Research Consortium type 2, 3 or 5.
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
- None
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
- •Acute Coronary Syndrome
- •Chronic Coronary Syndrome
- •Successful PCI
排除标准
- •Known allergy or contraindication for prasugrel, including Active pathological bleeding Severe liver disease (defined as Child Pugh class C)
- •Current indication for oral anticoagulant therapy (OAC)
- •Indication for ongoing DAPT (e.g. PCI ≤ 6 months for CCS or ACS ≤ 12 months)
- •Pregnancy or breast-feeding women
- •Participation in another trial with an investigational drug or device
- •Recent or ongoing use of CYP2B6 substrates with a narrow therapeutic window (e.g. cyclophosphamide, efavirenz)
研究组 & 干预措施
Intervention Arm
Prasugrel low-dose monotherapy
干预措施: Prasugrel 5 mg (Drug)
Control Arm
Dual antiplatelet therapy
干预措施: Dual Antiplatelet (DAPT) Therapy (Drug)
结局指标
主要结局
NACE (Net Adverse Clinical Events)
时间窗: 12 months
The primary endpoint is NACE, a composite of all-cause mortality, myocardial infarction, definite stent thrombosis, ischemic stroke, major bleeding or clinically relevant non-major bleeding defined as BARC type 2, 3 or 5
次要结局
未报告次要终点
研究者
J.P.S Henriques
Professor Doctor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)