Optimization of Antiplatelet Therapy With Clopidogrel on the Basis of the Extent of Platelet Inhibition in Patients With Acute Coronary Syndromes on Dual Antiplatelet Therapy Undergoing PCI With Stent Implantation
试验速览
- 阶段
- 3 期
- 入组人数
- 442
- 试验地点
- 1
- 主要终点
- Incidence of MACE (cardiovascular death, nonfatal myocardial infarction, target lesion vessel revascularization by PCI or coronary bypass)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy (reduction of major ischemic events at 6 and 12 months of follow-up) of a tailored clopidogrel therapy in patients with UA/NSTEMI undergoing PCI with stent implantation and wiht a documented residual platelet reactivity assessed by a point of care system (VerifyNow P2Y12).
详细描述
Several studies documented the presence of a high variability in the individual response to antiplatelet therapies in terms of extent of platelet function inhibition. This laboratory finding is the so-called aspirin or clopidogrel resistance which we prefer to define residual platelet reactivity (RPR) on antiplatelet therapy.
A growing body of evidence is demonstrating the clinical relevance of this laboratory parameter, i.e. patients with RPR are at higher risk of a subsequent adverse cardiovascular event.
In particular, it has been demonstrated that RPR measured by light transmittance aggregometry induced by ADP or by the point of care assay VerifyNow P2Y12 identifies patients which, after coronary revascularization with stent implantation, at higher risk of a potentially catastrophic event such as stent thrombosis.
No randomized trials are available in the literature on the efficacy and safety of an antiplatelet therapy tailored on the extent of platelet function inhibition.
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
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unstable or NSTEMI
排除标准
- •Previous bleeding events which have required blood transfusion
- •PT- INR >1.5
- •Platelet count ≤ 100000/ mm3
- •Hb < 10 g/dl
- •Previous TIA/stroke (ischemic or hemorrhagic or unknown)
- •Body weight < 60 Kg
- •Creatinine levels ≥ 4 mg/dl
- •Cerebral neoplasia
- •Recent major trauma/surgery/head injury (within 3 previous weeks)
- •Gastrointestinal hemorrhage in the last month
- •Aortic dissection
- •Known haemorrhagic diathesis
- •Oral anticoagulant therapy
- •Pregnancy or 1 week after delivery
- •Uncontrolled hypertension (systolic >180 mmHg or diastolic >110 mmHg)
- •Severe liver disease
- •Infective endocarditis
- •Major psychiatric disorders
- •Alcool or drug abuse
- •Active peptic ulcer Noncompressible arterial puncture within 14 days Prolonged cardiopulmonary resuscitation
研究组 & 干预措施
1: standard therapy
clopidogrel 75 mg/day
干预措施: comparison of different dosage of clopidogrel (Drug)
2: doubled therapy
clopidogrel 150 mg/day
干预措施: doubled therapy (Drug)
结局指标
主要结局
Incidence of MACE (cardiovascular death, nonfatal myocardial infarction, target lesion vessel revascularization by PCI or coronary bypass)
时间窗: 6 and 12 months
次要结局
- Stent thrombosis with angiographic confirmation; platelet function assessed by VerifyNow P2Y12 1 week after the randomization(1 week; 6 and 12 months)