Comparison of Therapy With TICAGRELOR, Prasugrel and High Clopidogrel Dose in PCI Patients With High on Treatment Platelet Reactivity and Genotype Variation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- antiplatelet effect of standard dose of prasugrel or ticagrelor versus high dose clopidogrel in stable patients with high reactivity
研究概览
简要总结
Dual antiplatelet therapy with Aspirin and Clopidogrel for at least one year is essential in patients following an acute coronary syndrome (ACS) or percutaneous coronary intervention (PCI) with drug eluting stent(s) implantation. Interindividual variability in platelet response to Clopidogrel has been reported, with several mechanisms (intrinsic high platelet reactivity [PR], variability of the drug metabolism, and various drug interactions) being implicated for high post-Clopidogrel treatment PR. The investigators aim to perform a prospective, single-center, investigator-initiated, randomized, study to compare platelet inhibition by Prasugrel 10 mg/day, Ticagrelor (90 mg twice daily) and high-dose 150 mg/day Clopidogrel in patients with High on-treatment platelet reactivity (HTPR) with standard dose of Clopidogrel. Patients with HTPR (defined as area under curve-AUC ≥ 450 or > 45 Unit) and with loss-of-function allele CYP2C19*2 will be enrolled in the study and will be randomized (Day 0) in a 1:1:1 ratio, to either Clopidogrel 150 mg a day or Prasugrel 10 mg a day or Ticagrelor (90 mg twice daily) until Day-15 and-30 post randomization.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients underwent to percutaneous coronary intervention (PCI)
- •clopidogrel resistance after Platelet reactivity blood test
排除标准
- •history of bleeding diathesis
- •chronic oral anticoagulation treatment
- •contraindications to antiplatelet therapy
- •PCI or coronary artery bypass grafting (CABG) < 3 months
- •hemodynamic instability
- •platelet count < 100,000/μl
- •hematocrit < 30%
- •creatinine clearance < 25 ml/min
- •Patients with a history of stroke
- •contraindication for prasugrel administration
- •patients weighing < 60 kg
- •> 75 years of age.
研究组 & 干预措施
Prasugrel standard dose
Patient will be randomized to this intervention will receive in the first time prasugrel and after 15 days and 30 days we will control the responsivness of the study drug.
干预措施: Prasugrel (Drug)
high clopidogrel dose
Patient will be randomized to this intervention will receive in the first time the high clopidogrel dose and after 15 days and 30 days we will control the responsivness of the study drug.
干预措施: Clopidogrel (Drug)
Ticagrelor standard dose
Patient will be randomized to this intervention will receive in the first time ticagrelor and after 15 days and 30 days we will control the responsivness of the study drug.
干预措施: Ticagrelor (Drug)
结局指标
主要结局
antiplatelet effect of standard dose of prasugrel or ticagrelor versus high dose clopidogrel in stable patients with high reactivity
时间窗: 30 days
the antiplatelet effect in terms of level platelet reactivity (\< 450 Area under the curve (AU\*min)) of standard dose of Prasugrel (10 mg/day) either Ticagrelor (90 mg twice daily) versus high dose Clopidogrel (150 mg/day) in patients undergoing PCI with high reactivity
次要结局
- Bleeding (major, minor, or minimal)(45 days)
- Major Adverse Cardiac Cerebrovascular Events(45 days)
研究者
Gennaro Sardella
Associate Professor in Cardiology
University of Roma La Sapienza