Evaluation of the Influence of Statins and Proton Pump Inhibitors on Clopidogrel Antiplatelet Effects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Percent change in residual platelet aggregation by light transmittance aggregometry and percent change in platelet reactivity index by VASP
研究概览
简要总结
There is conflicting evidence in the literature suggesting that the use of proton pump inhibitors (PPIs), and/or some statins can interfere with clopidogrel antiplatelet effect and result in adverse cardiovascular outcomes in patients treated with coronary artery stents and dual antiplatelet therapy.
The primary aim of the study is to determine the effect of various currently used PPI on platelet aggregation in patients undergoing percutaneous coronary intervention (PCI) and treated with dual antiplatelet therapy.
The secondary aim of the study is to evaluate how statins and 2C19*2 polymorphism modulate the effect of PPI on clopidogrel efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Subject must be 18 years of age or older
- •Bare metal stent implantation
- •Discharged with dual antiplatelet therapy for at least 60 days
- •Written informed consent
排除标准
- •Patients who do not consent to participate in the study
- •Premenopausal women not using contraceptive methods or without a negative pregnancy test in the past week
- •Patients treated or planned to be treated with oral anticoagulants
- •Present treatment with or clear indication for treatment with a PPI or H2 antagonists
- •Allergy or intolerance to study medications including ranitidine, Proton pump inhibitors, atorvastatin, rosuvastatin, aspirin and/or clopidogrel
- •Patient treated with a strong CYP2C19 interacting drug
- •History of a bleeding diathesis, or evidence of active abnormal bleeding within 30 days before enrollment
- •History of intracranial hemorrhage or intracranial surgery in the last 3 months
- •History of gastro-intestinal ulcers in the last 3 months
- •Any serious illness or any condition that the investigator feels would influence the impact of this therapy on the subject
- •Known platelet count < 100000/mm3 at time of enrollment or within 24 hours prior to enrollment
研究组 & 干预措施
Rosuvastatin-omeprazole
Rosuvastatin-omeprazole
干预措施: Rosuvastatin-omeprazole (Drug)
Rosuvastatin-pantoprazole
Rosuvastatin 20 mg for 1 month, then rosuvastatin 20 mg and pantoprazole 40 mg for 11 months
干预措施: Rosuvastatin-pantoprazole (Drug)
Rosuvastatin-esomeprazole
Rosuvastatin 20 mg for 1 month, then rosuvastatin 20 mg and esomeprazole 40 mg for 11 months
干预措施: Rosuvastatin-esomeprazole (Drug)
Rosuvastatin-ranitidine
Rosuvastatin 20 mg for 1 month, then rosuvastatin 20 mg and ranitidine 300 mg for 11 months
干预措施: Rosuvastatin-ranitidine (Drug)
Atorvastatin-omeprazole
Atorvastatin 80mg for 1 month, then atorvastatin 80 mg and omeprazole 20 mg for 11 months
干预措施: Atorvastatin-omeprazole (Drug)
Atorvastatin-pantoprazole
Atorvastatin 80mg for 1 month, then atorvastatin 80 mg and pantoprazole 40mg for 11 months
干预措施: Atorvastatin-pantoprazole (Drug)
Atorvastatin-esomeprazole
Atorvastatin 80mg for 1 month, then atorvastatin 80 mg and esomeprazole 40 mg for 11 months
干预措施: Atorvastatin-esomeprazole (Drug)
Atorvastatin-ranitidine
Atorvastatin 80mg for 1 month, then atorvastatin 80 mg and ranitidine 300mg for 11 months
干预措施: Atorvastatin-ranitidine (Drug)
结局指标
主要结局
Percent change in residual platelet aggregation by light transmittance aggregometry and percent change in platelet reactivity index by VASP
时间窗: At 30 and 60 days
次要结局
- Prevalence and role of CYP 2C19*2 polymorphism on the effect of PPIs and statins on the antiplatelet activity of clopidogrel(30 and 60 days)
- Resistance to clopidogrel by light transmittance aggregometry (defined by RPA >55%), resistance to clopidogrel by vasodilator-stimulated phosphoprotein (VASP) (defined by PRI >55%)(30 and 60 days)
- The composite of death from all causes, myocardial infarction, ischemia-driven repeat revascularization, and stroke(30 days, 60 days and 1 year)
- Need to stop any antiplatelet medication for gastrointestinal bleeding or peptic ulcer disease(30 days, 60 days and one year)
研究者
Jean-Pierre Dery, MD, MSc
Interventional Cardiologist
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec