Possible Drug Interaction Between Clopidogrel and Ranitidin or Omeprazole in Patients With Stable Coronary Heart Disease: a Comparative Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 92
- 主要终点
- Comparing Platelet Function of Patients on Dual Antiplatelet Therapy With ASA + Clopidogrel, Between the Groups Ranitidin and Omeprazole, After One Week of Randomized Treatment
研究概览
简要总结
Previous reports have shown a possible drug interaction between clopidogrel and proton pump inhibitors (PPI´s), which could result in increased number of adverse cardiovascular events among patients on dual antiplatelet therapy(DAPT). Because of this, ranitidin has been proposed as an alternative drug to PPI´s for prophylaxis of gastrointestinal bleeding in patients who need DAPT. The study´s aim is to test the hypothesis that ranitidin doesn´t have any influence on clopidogrel pharmacodynamic.
详细描述
Study population: 100 patients with Stable Coronary Artery Disease from Heart Institute
Inclusion Criteria:
- Age > 18 years old
- Coronary artery disease, defined as previous myocardial infarction and/or coronary angioplasty and/or Coronary Artery Bypass Graft (CABG) surgery and/or coronariography showing obstruction of at least 50 % in one of major epicardial vessels
- Treatment with Acetylsalicylic Acid (ASA) 100 mg/day
Exclusion Criteria:
- Use in the last 7 days of oral anticoagulant or any other antiplatelet drug beside ASA
- Previous utilization of PPI or ranitidine in the last 7 days before randomization
- Active bleeding
- Pregnancy or woman of childbearing age without contraceptive method
- Hemoglobin < 10 g/dL or hematocrit < 30 %, hematocrit > 50 %, platelets < 100.000/mm3 or > 500.000/mm3; creatinin clearance < 50 ml/minute
- Percutaneous coronary intervention (PCI) on the last 30 days before randomization (or PCI on the last year when drug-eluted stents are used); CABG surgery on the last 90 days; acute coronary syndrome on the last 60 days
- Active malignant neoplasm
- Active peptic ulcer disease on the last 60 days or upper gastrointestinal bleeding any time in life
- Known allergy to the drugs clopidogrel, ranitidine or omeprazole
- Refuse to participate in the study]
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age > 18 years old
- •Coronary artery disease, defined as previous myocardial infarction and/or coronary angioplasty and/or CABG surgery and/or coronariography showing obstruction of at least 50 % in one of major epicardial vessels
- •Treatment with Acetylsalicylic Acid (ASA) 100 mg/day
排除标准
- •Use on the last 7 days of any other antiplatelet drug beside ASA or oral anticoagulant
- •Previous utilization of PPI or ranitidine in the last 7 days before randomization
- •Any active bleeding
- •Pregnancy or woman of childbearing age without contraceptive method
- •Hemoglobin < 10 g/dL or hematocrit < 30 %, hematocrit > 50 %, platelets < 100.000/mm3 or > 500.000/mm3; creatinin clearance < 50 ml/minute
- •Percutaneous coronary intervention (PCI) on the last 30 days before randomization (or PCI on the last year when drug-eluted stents are used); CABG surgery on the last 90 days; acute coronary syndrome on the last 60 days
- •Active malignant neoplasm
- •Active peptic ulcer disease on the last 60 days or upper gastrointestinal bleeding any time in life
- •Known allergy to the drugs clopidogrel, ranitidine or omeprazole
- •Refuse to participate in the study
研究组 & 干预措施
omeprazole
Omeprazole 20 mg (oral route) twice a day will be given to the subjects for one week. This intervention will be compared with ranitidin 150 mg (oral route) twice a day.
干预措施: omeprazole (Drug)
omeprazole
Omeprazole 20 mg (oral route) twice a day will be given to the subjects for one week. This intervention will be compared with ranitidin 150 mg (oral route) twice a day.
干预措施: Clopidogrel (Drug)
ranitidine
Ranitidine 150 mg (oral route) twice a day will be given to the subjects for one week.
干预措施: Ranitidine (Drug)
ranitidine
Ranitidine 150 mg (oral route) twice a day will be given to the subjects for one week.
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Comparing Platelet Function of Patients on Dual Antiplatelet Therapy With ASA + Clopidogrel, Between the Groups Ranitidin and Omeprazole, After One Week of Randomized Treatment
时间窗: One week after randomized treatment exposure (omeprazole or ranitidine)
One week after starting double-blind, double-dummy, randomized therapy with ranitidin or omeprazole on patients treated with DAPT, platelet function will be compared with the method VerifyNow, in P2Y12 Reactivity Units.
Comparing Platelet Function of Patients on Dual Antiplatelet Therapy With ASA + Clopidogrel, Between the Groups Ranitidin and Omeprazole, Using VerifyNow Method.
时间窗: One week after drug exposure (omeprazole/ranitidine); 2 weeks after baseline
One week after starting double-blind, double-dummy, randomized therapy with ranitidin or omeprazole on patients treated with DAPT, platelet function will be compared with the method VerifyNow, in percent Inhibition of Platelet Aggregation (IPA) from baseline. IPA was calculated as the percent change in aggregability from baseline, with the formula IPA = (on-treatment aggregability minus baseline aggregability)/baseline aggregability. Since baseline aggregation is always, per definition, equal or more than on-treatment aggregation, there is no possibility that this number might be negative.
次要结局
未报告次要终点