Rapid Activity of Platelet Inhibitor Drugs Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Residual platelet reactivity by VerifyNow
研究概览
简要总结
The aim of the RAPID study is to assess the rapid onset of action of the 2 novel oral antiplatelet agents, Prasugrel and Ticagrelor, in 50 patients with STEMI undergoing PPCI with bivalirudin monotherapy.
详细描述
Fifty consecutive patients with STEMI undergoing PPCI with bivalirudin (GP IIb/IIIa not allowed ) will be randomized to receive 60 mg Prasugrel loading dose (n= 25) or 180 Ticagrelor loading dose (n= 25) before PPCI. The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In the case of vomit in the 2 hours after drug loading dose a new loading dose will be administered. All interventions will be performed by the femoral approach according to current standards. The use of thrombectomy before infarct-related artery stenting, of everolimus eluting stent and of closure devices will be strongly encouraged. Bivalirudin will be administered as a bolus 0.75 mg/kg followed by 1.75 mg/kg/h infusion during PCI. After PCI a reduced bivalirudin infusion of 0.25 mg/kg/h for 4 hours will be allowed. Dual antiplatelet therapy (100 mg aspirin associated with 5 or 10 mg Prasugrel or 180 mg Ticagrelor) will be recommended for 12 months.
Residual platelet reactivity will be assessed in all patients at baseline (time of loading dose), and after 2, 4, 8 and 12 hours by a point-of-care test VerifyNow bedside available in the Intensive cardiac care Unit. High residual platelet reactivity will be defined as a Platelet Reactivity Units (PRU) > 240 by VerifyNow. At the same time point, Activated Clotting Time (ACT) will be also assessed. Follow-up will be performed by outpatient visits or telephone interviews at 6 months.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting within 12 hours from the onset of symptoms with STEMI
- •Informed, written consent
排除标准
- •Age < 18 years
- •Active bleeding; bleeding diathesis; coagulopathy
- •History of gastrointestinal or genitourinary bleeding <2 months
- •Major surgery in the last 6 weeks
- •History of intracranial bleeding or structural abnormalities
- •Suspected aortic dissection
- •Any previous TIA/stroke
- •Administration in the week before the index event of clopidogrel, ticlopidine, prasugrel, ticagrelor, thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux, GPI.
- •Known relevant hematological deviations: Hb <10 g/dl, Platelet count <100x10^9/l
- •Use of coumadin derivatives within the last 7 days
- •Chronic therapy with prasugrel or ticagrelor
- •Known malignancies or other comorbid conditions with life expectancy <1 year
- •Known severe liver disease, severe renal failure
- •Known allergy to the study medications
研究组 & 干预措施
Prasugrel loading dose
干预措施: Prasugrel (Drug)
Ticagrelor Loading dose
干预措施: Ticagrelor (Drug)
结局指标
主要结局
Residual platelet reactivity by VerifyNow
时间窗: 2 hours
Residual platelet reactivity will be assessed in all patients at baseline (time of loading dose), and after 2 hours by a point-of-care test VerifyNow bedside available in the Intensive cardiac care Unit.
次要结局
- High residual platelet reactivity(2,4,8,12 hours)
研究者
David Antoniucci
Head Division of Invasive Cardiology
Careggi Hospital