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

Completed

• Conditions: Coronary Artery Disease; Peripheral Artery Disease

• Registration Number: NCT01018940
• Lead Sponsor: University of Oklahoma

Brief Summary

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).

Detailed Description

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).

Study Timeline

• Study First Submitted: 2009-11-23
• Study First Submitted QC: 2009-11-23
• Study First Posted: 2009-11-25
• Study Start: 2010-01
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States