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).

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Peripheral Artery Disease

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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73190
      • University of Oklahoma Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with Coronary or Peripheral Artery Disease

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Plavix
Prasugrel

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Jorge Saucedo, MD, Dept of Cardiology

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: November 23, 2009
• First Submitted That Met QC Criteria: November 23, 2009
• First Posted (Estimate): November 25, 2009

Study Record Updates

• Last Update Posted (Estimate): December 4, 2014
• Last Update Submitted That Met QC Criteria: December 2, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Coronary Disease; Peripheral Vascular Diseases; Coronary Artery Disease; Peripheral Arterial Disease
• Other Study ID Numbers: 14882