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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01018940
• Other study ID #: 14882
• Status: Completed
• Phase: N/A
• First received: November 23, 2009
• Last updated: December 2, 2014
• Start date: January 2010
• Est. completion date: June 2011

Study information

• Verified date: December 2014
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Peripheral Arterial Disease
• Peripheral Artery Disease

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States,