Influence of the Proton Pump Inhibitor Omeprazole on the Anti-Platelet of P2Y12 Antagonists in Subjects With Coronary and Peripheral Artery Disease

Official Title: “Influence of the Proton Pump Inhibitor Omeprazole on the Anti-Platelet of P2Y12 Antagonists in Subjects With Coronary and Peripheral Artery Disease”

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).

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).

Arms, Groups and Cohorts in this Clinical Trial

• : Plavix
• : Prasugrel

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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:
• 1. Prior history of hemorrhagic stroke or transient ischemic attack (TIA)
• 2. Intracranial neoplasm, arteriovenous malformation, or aneurysm
• 3. 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: University of Oklahoma Other

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01018940

Study ID Number: OUHSC IRB 14882

ClinicalTrials.gov Identifier: NCT01018940

Health Authority: United States: Institutional Review Board