Atorvastatin and Clopidogrel HIgh DOse in Stable Patients With Residual High Platelet Activity
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
- Change from baseline in on-treatment platelet reactivity at 7 and 30 days
研究概览
简要总结
The purpose of this study is to evaluate if high-dose (80mg/day) atorvastatin might exert an adjunctive anti-platelet effect compared to high-dose clopidogrel (150mg/day) in stable patients with high on-treatment reactivity according to a point-of-care platelet function assay.
详细描述
This is a prospective, randomized, open-label, control-active trial performed in elective patients candidates to coronary drug eluting stent implantation who presented high-on-treatment platelet reactivity, immediately before coronary intervention (PCI). All patients are treated with aspirin (100 mg/day) and standard-dose clopidogrel (600 mg as loading dose and 75 mg daily as maintenance dose)for at least 7 days before PCI. Platelet function is assessed by the VerifyNow P2Y12 assay (Accumetrics, San Diego, CA). Patients are eligible to be enrolled if they have high-on-treatment reactivity defined as P2Y12 reaction units (PRU) >= 230, immediately before PCI. After PCI, patients are randomized to receive high-dose clopidogrel (150 mg daily) or high-dose atorvastatin (80mg/day) + high-dose clopidogrel (150 mg daily). Study visits and platelet function testing with the VerifyNow P2Y12 test are conducted at 7 and 30 days after 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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable angina
- •candidates to drug eluting stent implantation
- •High on-treatment platelet reactivity according to a point-of-care platelet function test
排除标准
- •chronic therapy with statins
- •inability to provide informed consent
- •intolerance to statins
- •acute or chronic liver failure or ALT > 2 times ULN
- •known myopathy
- •CKD stage IV or dialysis treatment
- •pregnancy or breast-feeding
- •malignancy
研究组 & 干预措施
Atorvastatin-Clopidogrel group
Patients who receive Atorvastatin 80 mg/day and Clopidogrel 150 mg/day
干预措施: atorvastatin and clopidogrel (Drug)
Clopidogrel group
Patients who receive clopidogrel 150 mg daily
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Change from baseline in on-treatment platelet reactivity at 7 and 30 days
时间窗: pre-PCI, 7 days and 30 days
Pharmacodynamic analysis of the randomized groups includes a) assessment of the absolute level of on-treatment reactivity, b) change in on-treatment reactivity, c) rate of high on-treatment reactivity at 7 and 30 days. The platelet reactivity is measured with the VerifyNow P2Y12 test (Accumetrics, SanDiego, CA).
次要结局
未报告次要终点
研究者
Toso Anna
MD
Ospedale Misericordia e Dolce