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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

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ClinicalTrials.gov Identifier: NCT01018940
Recruitment Status : Completed
First Posted : November 25, 2009
Last Update Posted : December 4, 2014
Information provided by (Responsible Party):
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).

Condition or disease
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
Actual Enrollment : 30 participants
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
Study Start Date : January 2010
Primary Completion Date : June 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Omeprazole
U.S. FDA Resources


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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT01018940     History of Changes
Other Study ID Numbers: 14882
First Posted: November 25, 2009    Key Record Dates
Last Update Posted: December 4, 2014
Last Verified: December 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