NCT01018940已完成不适用
Influence of the Proton Pump Inhibitor Omeprazole on the Anti-Platelet of P2Y12 Antagonists in Subjects With Coronary and Peripheral Artery Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
To determine if prasugrel is superior to clopidogrel in providing adequate antiplatelet effect in a high risk population that requires concomitant use of a Proton Pump Inhibitor (PPI).
详细描述
To evaluate if simultaneous treatment with the PPI omeprazole and a P2Y12 receptor antagonist will influence the effect of either clopidogrel and/or prasugrel on platelet reactivity in patients with Coronary Artery Disease (CAD) or Peripheral Arterial Disease (PAD).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults between 18 and 75 years of age
- •Known or documented history of CAD or PAD prior to enrollment (a diagnosis of CAD may be based upon a positive stress test, prior documented acute coronary event, or angiographic demonstration of CAD; a diagnosis of PAD may be based upon an ankle-brachial index less than 0.9, or angiographic demonstration of PAD)
- •Have not had thienopyridine therapy for at least 15 days before the study
- •Have not had treatment with a PPI for at least 15 days before the study
- •Are taking aspirin (75 to 325 mg/day) for at least one week prior to randomization
排除标准
- •Have New York Heart association (NYHA) Class III and IV congestive heart failure
- •Have any form of coronary revascularization (PCI or coronary artery bypass grafting [CABG]) planned to occur during the study
- •Have undergone PCI or CABG within 30 days of entry to the study
- •Have received a drug eluting endovascular stents in the past year
- •Have any of the following:
- •Prior history of hemorrhagic stroke or transient ischemic attack (TIA)
- •Intracranial neoplasm, arteriovenous malformation, or aneurysm
- •A body weight less than 60 kg
- •Have prior history of GI ulcer disease or bleeding
- •Have symptoms of dyspepsia or gastroesophageal reflux disease
- •Have active internal bleeding or history of bleeding diathesis
- •Have clinical findings, in the judgment of the investigator, associated with an increased risk of bleeding
- •Have an International Normalized Ratio (INR) known to be >1.5 at the time of evaluation
- •Have a platelet count of <100,000/mm3 at the time of screening, if known
- •Have anemia (hemoglobin [Hgb] <10 gm/dL) at the time of screening, if known
- •Are receiving or will receive oral anticoagulation or other antiplatelet therapy (other than aspirin) that cannot be safely discontinued for the duration of the study
- •Are receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) that cannot be discontinued or require daily treatment with NSAIDs during the study.
- •Are receiving corticosteroid therapy
研究者
研究点 (1)
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