Prasugrel Or Ticagrelor In ST-Elevation Myocardial Infarction Patients With Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- the superiority antiplatelet effect in terms of PR level of loading dose (LD) of Prasugrel (60 mg) versus LD of Ticagrelor (180 mg) in diabetic patients with STEMI undergoing primary PCI at 2 hours post drug administration.
研究概览
简要总结
Dual antiplatelet therapy is essential in patients following ST-Elevation myocardial infarction (STEMI) with percutaneous coronary intervention (PCI) and drug eluting stent implantation. Current guidelines recommend prasugrel and ticagrelor in patients with STEMI undergoing primary PPCI. We sought to investigate the superiority antiplatelet effect in terms of PR level of loading dose (LD) of Prasugrel (60 mg) versus LD of Ticagrelor (180 mg) in diabetic patients with STEMI undergoing primary PCI at 1 and 2 hours post drug administration. Secondary end-points will be: PR level measured at 6 and 12 hours post study drugs administrationin hospital. All consecutive diabetic patients with STEMI undergoing PPCI with stent implantation will be considered for PR assessment at 1-2-6-12 h after the drug LD administration. All patients must will be naïve for platelet P2Y12 receptor inhibition therapy. A subanalysis will be performed between two study groups according to insulin treatment.
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
- •Diabetic patients
- •acute coronary syndrome
- •patients underwent to primary PCI
- •naïve for platelet P2Y12 receptor inhibition therapy
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
- •patients treated with morphine
- •> 75 years of age.
研究组 & 干预措施
Prasugrel loading dose
Patients will be randomized to this arm to receive loading dose of prasugrel
干预措施: ticagrelor (Drug)
Prasugrel loading dose
Patients will be randomized to this arm to receive loading dose of prasugrel
干预措施: prasugrel (Drug)
结局指标
主要结局
the superiority antiplatelet effect in terms of PR level of loading dose (LD) of Prasugrel (60 mg) versus LD of Ticagrelor (180 mg) in diabetic patients with STEMI undergoing primary PCI at 2 hours post drug administration.
时间窗: 1 and 2 hours
次要结局
- PR level measured at 6 and 12 hours post study drugs administration.(in hospital)
研究者
Gennaro Sardella
Associate Professor in Cardiology
University of Roma La Sapienza