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

This study has been completed.
Information provided by (Responsible Party):
University of Oklahoma Identifier:
First received: November 23, 2009
Last updated: December 2, 2014
Last verified: December 2014
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).

Coronary Artery Disease Peripheral Artery Disease

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Influence of the Proton Pump Inhibitor Omeprazole on the Anti-Platelet of P2Y12 Antagonists in Subjects With Coronary and Peripheral Artery Disease

Resource links provided by NLM:

Further study details as provided by University of Oklahoma:

Biospecimen Retention:   Samples With DNA
Blood specimens for platelet activity and genotyping

Enrollment: 30
Study Start Date: January 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)

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).

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with Coronary or Peripheral Artery Disease

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
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Please refer to this study by its identifier: NCT01018940

United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73190
Sponsors and Collaborators
University of Oklahoma
Principal Investigator: Jorge Saucedo, MD Dept of Cardiology
  More Information

Responsible Party: University of Oklahoma Identifier: NCT01018940     History of Changes
Other Study ID Numbers: 14882
Study First Received: November 23, 2009
Last Updated: December 2, 2014

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Peripheral Arterial Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Peripheral Vascular Diseases
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on August 22, 2017