Clinical trial NCT01018940: Influence of the Proton Pump Inhibitor Omeprazole on the Anti-Platelet of P2Y12 Antagonists in Subjects With Coronary and Peripheral Artery Disease
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Peripheral Artery Disease
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2009-11-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Coronary or Peripheral Artery Disease

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).

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: Dept of Cardiology
name: Jorge Saucedo, MD
role: PRINCIPAL_INVESTIGATOR
References: