PhaRmacodynamic Effect of Antiplatelet Agents in Elderly Patients: Standard Clopidogrel Versus prasugrEl Low Dose Therapy.
试验速览
- 阶段
- 3 期
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- superiority of prasugrel low dose
研究概览
简要总结
The elderly represent a growing segment of the coronary population treated by dual antiplatelet therapy for percutaneous coronary intervention (PCI). These patients bear a higher risk of both ischemic events and bleeding complications than younger patients, with a subsequently higher rate of mortality.Recentprogress in antithrombotic treatment demonstrated the efficacy of adding a P2Y12 receptor antagonist to low-dose aspirin. Whether this benefit is also present in the elderly remains a debated issue due to the lack of specific data in this sub-population. The present study was realized to provide specific data on platelet response to clopidogrel, standard dose (75 mg) or prasugrel 5 mg in elderly patients (≥75 years old) whereas the superiority in PR response of the latter should allows the Prasugrel therapy in elderly patients with the better clinical efficacy and therapeutical safety already showed compared with Clopidogrel.
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
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute coronary syndrome
- •PCI with stent implantation
- •clopidogrel responsiveness
- •> 75 years of age.
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
- •other contraindication for prasugrel administration
- •patients weighing < 60 kg
- •high on treatment platelet reactivity
研究组 & 干预措施
Prasugrel low dose
Patient will be randomized to this intervention will receive prasugrel 5 mg and after 15 days and 30 days we will control the responsivness of the study drug.
干预措施: Prasugrel (Drug)
Clopidogrel standard dose
Patient will be randomized to this intervention will receive clopidogrel 75 mg and after 15 days and 30 days we will control the responsivness of the study drug.
干预措施: Clopidogrel (Drug)
结局指标
主要结局
superiority of prasugrel low dose
时间窗: 30 days
The primary aim will be to investigate the antiplatelet effect of half dose of prasugrel (5 mg) versus standard dose of clopidogrel in patients with acute coronary syndrome and coronary diseases, treated with percutaneous coronary intervention and stent implantation.
次要结局
- Bleeding(12 months)
- major adverse cardiac events(12 months)
研究者
Gennaro Sardella
Associate Professor in Cardiology
University of Roma La Sapienza