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

November 23, 2009
February 6, 2012
January 2010
August 2011   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT01018940 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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
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).

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).

Observational
Observational Model: Case-Crossover
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood specimens for platelet activity and genotyping

Probability Sample

Patients with Coronary or Peripheral Artery Disease

  • Coronary Artery Disease
  • Peripheral Artery Disease
Not Provided
  • Plavix
  • Prasugrel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
October 2012
August 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01018940
OUHSC IRB 14882
Yes
University of Oklahoma
University of Oklahoma
Not Provided
Not Provided
University of Oklahoma
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP