Comparison of the Pharmacodynamic Effects of RanOlazine Versus aMlodipine on Platelet Reactivity in Stable Patients With Coronary Artery Disease Treated With Dual ANtiplatelet Therapy - The ROMAN Randomized Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Assessment of platelet reaction units
研究概览
简要总结
No previous study has assessed the potential of ranolazine to interfere with levels of platelet reactivity in patients with coronary artery disease who are treated with dual antiplatelet therapy.
Aim of this study is to compare the pharmacodynamic effects of maintenance doses of ranolazine versus amlodipine on platelet reactivity in patients with coronary artery disease who are treated with dual antiplatelet therapy.
详细描述
Patients with coronary artery disease (CAD) are often treated with dual antiplatelet therapy (DAT), including aspirin and clopidogrel, to prevent from recurrent atherothrombotic events.
Levels of platelet reactivity in patients on DAT can be influenced by concomitant treatment with medications that inhibit the CYP3A4 system involved in the activation of clopidogrel, such as calcium channel blockers, potentially interfering with its clinical benefits. Importantly, calcium channel blockers, such as amlodipine, are commonly used for relief of ischemic symptoms in patients with CAD.
Ranolazine is a novel antianginal drug that reduces intracellular sodium and calcium accumulation and constitutes a pharmacologic alternative to calcium channel blockade.
However, no previous study has assessed the potential of ranolazine to interfere with levels of platelet reactivity in CAD patients on DAT.
The primary objective of this study is to compare the pharmacodynamic effects of maintenance doses of ranolazine versus amlodipine on platelet reactivity in patients with CAD on DAT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Angiographically-proven coronary artery disease
- •Class I indication to dual antiplatelet therapy because of recent (<12 months) percutaneous coronary intervention and/or recent acute coronary syndrome (<12 months)
- •Stable clinical conditions
- •Able to understand and willing to sign the informed consent form
排除标准
- •Use of other drug interfering with CYP activity such as proton pump inhibitors
- •Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before
研究组 & 干预措施
Ranolazine
Patients will receive ranolazine (750 mg bid) for 15 days
干预措施: Ranolazine (Drug)
Amlodipine
Patients will receive amlodipine (10 mg once daily) for 15 days
干预措施: Amlodipine (Drug)
结局指标
主要结局
Assessment of platelet reaction units
时间窗: After 15 days of treatment with each drug
Absolute changes in platelet reactivity (expressed as P2Y(12) reaction units by the point-of-care VerifyNow assay \[Accumetrics, San Diego, California\])
次要结局
- Frequency of high platelet reactivity(After 15 days of treatment with each drug)
研究者
Francesco Pelliccia
Assistant Professor
University of Roma La Sapienza