Influence of the Proton Pump Inhibitor Omeprazole on the Anti-Platelet of P2Y12 Antagonists in Subjects With Coronary and Peripheral Artery Disease
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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).
Condition or disease
Coronary Artery DiseasePeripheral Artery Disease
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).
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Ages Eligible for Study:
18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with Coronary or Peripheral Artery Disease
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
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.