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

NCT01018940 | Completed DMC

• 1 other identifier: 14882
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Coronary Artery Disease; Peripheral Artery Disease

Study Arms (2)

Plavix

Prasugrel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Coronary or Peripheral Artery Disease

You may qualify if:

• 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

You may not qualify if:

• 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:
• Prior history of hemorrhagic stroke or transient ischemic attack (TIA)
• Intracranial neoplasm, arteriovenous malformation, or aneurysm
• 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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73190, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood specimens for platelet activity and genotyping

MeSH Terms

Conditions

Coronary Artery Disease; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Atherosclerosis; Peripheral Vascular Diseases

Study Officials

• Jorge Saucedo, MD

  Dept of Cardiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2009
• First Posted: November 25, 2009
• Study Start: January 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: December 4, 2014

Record last verified: 2014-12

Locations

US (1)