Intensified Loading With Prasugrel Versus Standard Loading With Clopidogrel in Invasive-treated Patients With Biomarker-Negative Angina Pectoris
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 795
- 试验地点
- 5
- 主要终点
- Combined ischemic events
研究概览
简要总结
Use of high loading doses of clopidogrel (antiplatelet drug) just before coronary interventions is associated with improved outcomes after coronary stenting. However the onset of platelet inhibition after clopidogrel loading takes 2 to 4 hours and its action if very variable. A way to overcome this limitation is loading with a more potent antiplatelet drug such as prasugrel. Therefore in the current study the investigators want to compare loading with 60 mg prasugrel (potent antiplatelet drug) and loading with clopidogrel (standard drug) in patients undergoing elective coronary intervention.
详细描述
Patients with stable or clinically unstable (biomarker-negative) angina pectoris who are in need of coronary intervention will be randomly assigned in one of the treatment strategies - 60 mg of prasugrel or 600 mg clopidogrel just prior to percutaneous coronary intervention (PCI). After PCI all patients will receive clopidogrel 75 mg/d as per standard. The patients will be monitored throughout a 30-day time frame and ischemic and bleeding events will be recorded. The study is powered to show the superiority of single-dose 60 mg prasugrel over single-dose 600 mg clopidogrel regarding the ischemic complications at 30-day follow-up.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with biomarker negative stable or unstable angina pectoris
- •Written informed consent
- •In women with childbearing potential a pregnancy test is obligatory
排除标准
- •Age < 18 years and >80 years
- •ST-elevation MI
- •Elevated cardiac biomarkers
- •Subjects with known contraindications to clopidogrel treatment, which are hypersensitivity to the drug substance or any component of the product and active pathological bleeding such as peptic ulcer or intracranial hemorrhage and with known severe liver disease (Child Pugh Class C)
- •Subjects with known contraindications to prasugrel treatment, which are hypersensitivity to the drug substance or any component of the product, active pathological bleeding such as peptic ulcer or intracranial hemorrhage and a history of prior transient ischemic attack (TIA) or stroke and with known severe liver disease (Child Pugh Class C)
- •Chronic therapy on potent P2Y12 receptor inhibitors (ticagrelor, prasugrel)
- •Pre-treatment with a loading dose of either clopidogrel, prasugrel or ticagrelor
- •Simultaneous participation in another clinical trial that involves the administration of an investigational medicinal drug within 30 days prior to the start of this clinical trial
- •Major surgeries in the last 6 weeks and planned surgeries within the next 6 weeks (per decision of the treating physician)
- •Active bleeding
- •Known or persistent abuse of medication, drugs or alcohol
- •Current or planned pregnancy or nursing women, women 90 days after childbirth. Females of childbearing potential, who do not use and are not willing to use medically reliable methods of contraception for the entire study duration (such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices) unless they are surgically sterilized / hysterectomized or there are any other criteria considered sufficiently reliable by the investigator in individual cases
研究组 & 干预措施
Prasugrel
single-dose loading with 60 mg of prasugrel pre PCI
干预措施: Prasugrel (Drug)
Clopidogrel
loading with 600 mg of clopidogrel pre PCI
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Combined ischemic events
时间窗: 30 days
Combined outcome of all-cause death, any myocardial infarction (MI), stent thrombosis, urgent revascularization and stroke
次要结局
- Stent thrombosis(30 days)
- Urgent vessel revascularization(30 days)
- cerebro-vascular events(30 days)
- Any myocardial infarction(30 days)
- Bleeding(30 days)
- Peri-PCI MI Type 4a(30 days)
- All-cause death(30 days)
研究者
Prof. Dr. Julinda Mehilli
Prof. Dr. med.
LMU Klinikum