Comparison of Circadian Variability of Platelet Inhibition in Patients With Myocardial Infarction Treated With Prasugrel and Ticagrelor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- Circadian variability of platelet inhibition assessed with VASP
研究概览
简要总结
The aim of this study is to compare circadian variability of antiplatelet effect of prasugrel and ticagrelor maintenance doses during the initial days after acute myocardial infarction.
详细描述
Prasugrel and ticagrelor are two oral P2Y12 receptor antagonists recommended as a part of dual antiplatelet therapy with aspirin in patients with acute myocardial infarction. Both drugs exert comparable antiplatelet effect following a loading dose. However, pharmacodynamic differences exist between these P2Y12 receptor inhibitors. Prasugrel is a prodrug that requires hepatic activation and permanently binds to platelet P2Y12 receptors, whereas ticagrelor is an active drug and blocks P2Y12 receptors reversibly. Another important difference is that prasugrel maintenance dose is administered once daily, while ticagrelor requires next dosage every 12 hours. These fundamental distinctions may affect the degree of platelet inhibition on maintenance doses during the first days after acute myocardial infarction.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •provision of informed consent prior to any study specific procedures
- •diagnosis of acute ST-segment elevation myocardial infarction or acute non-ST-segment elevation myocardial infarction
- •male or non-pregnant female, aged 18-75 years old
- •provision of informed consent for angiography and percutaneous coronary intervention
排除标准
- •treatment with ticlopidine, clopidogrel, prasugrel or ticagrelor within 14 days before the study enrollment
- •hypersensitivity to ticagrelor or prasugrel
- •contraindications for ticagrelor or prasugrel
- •current treatment with oral anticoagulant or chronic therapy with low-molecular-weight heparin
- •active bleeding
- •history of ischemic stroke or transient ischemic attack
- •history of intracranial hemorrhage
- •recent gastrointestinal bleeding (within 30 days)
- •history of moderate or severe hepatic impairment
- •history of major surgery or severe trauma (within 3 months)
- •patient required dialysis
- •manifest infection or inflammatory state
- •concomitant therapy with strong CYP3A inhibitors (ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir) or strong CYP3A inducers (rifampicin, phenytoin, carbamazepine, dexamethasone, phenobarbital) within 14 days and during study treatment
- •body weight below 60 kg
研究组 & 干预措施
Prasugrel
Patients with myocardial infarction will receive prasugrel as a part of dual antiplatelet therapy with aspirin.
干预措施: Prasugrel (Drug)
Ticagrelor
Patients with myocardial infarction will receive ticagrelor as a part of dual antiplatelet therapy with aspirin.
干预措施: Ticagrelor (Drug)
结局指标
主要结局
Circadian variability of platelet inhibition assessed with VASP
时间窗: Day 4 after acute myocardial infarction
Platelet inhibition evaluated with VASP assay at 8:00, 12:00, 16:00 and 20:00
Circadian variability of platelet inhibition assessed with Multiplate
时间窗: Day 4 after acute myocardial infarction
Platelet inhibition evaluated with Multiplate at 8:00, 12:00, 16:00 and 20:00
次要结局
- High platelet reactivity at 8:00 assessed with VASP(Day 4 after acute myocardial infarction)
- High platelet reactivity at 12:00 assessed with VASP(Day 4 after acute myocardial infarction)
- High platelet reactivity 16:00 assessed with VASP(Day 4 after acute myocardial infarction)
- High platelet reactivity 20:00 assessed with Multiplate(Day 4 after acute myocardial infarction)
- High platelet reactivity 20:00 assessed with VASP(Day 4 after acute myocardial infarction)
- High platelet reactivity 08:00 assessed with Multiplate(Day 4 after acute myocardial infarction)
- High platelet reactivity 12:00 assessed with Multiplate(Day 4 after acute myocardial infarction)
- High platelet reactivity 16:00 assessed with Multiplate(Day 4 after acute myocardial infarction)
研究者
Jacek Kubica
Prof. dr hab.
Collegium Medicum w Bydgoszczy