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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by University of Oklahoma.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT01018940
First received: November 23, 2009
Last updated: February 6, 2012
Last verified: February 2012
  Purpose

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
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


Estimated Enrollment: 30
Study Start Date: January 2010
Estimated Study Completion Date: October 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Plavix
Prasugrel

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).

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with Coronary or Peripheral Artery Disease

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01018940

Locations
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73190
Sponsors and Collaborators
University of Oklahoma
  More Information

No publications provided

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT01018940     History of Changes
Other Study ID Numbers: OUHSC IRB 14882
Study First Received: November 23, 2009
Last Updated: February 6, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Peripheral Arterial Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Atherosclerosis
Peripheral Vascular Diseases
Omeprazole
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014