Clopidogrel and the Optimization of Gastrointestinal Events (COGENT-1)

Inclusion Criteria:

• Patients in whom a requirement for clopidogrel therapy with concomitant aspirin isanticipated for at least the next 12 months. Specific conditions that may confer aneed for long-term clopidogrel + aspirin therapy may include non-ST segment elevationacute coronary syndrome (unstable angina/non-Q-wave MI), ST segment elevation acuteMI), or new placement of a coronary artery stent.

• For women of childbearing potential, negative pregnancy test prior to randomizationand agreement to use effective method of birth control during the study.

• Able to provide written informed consent based on competent mental status.

Exclusion Criteria:

• Patients currently hospitalized for whom discharge is not anticipated within 48 hoursof randomization.

• Requirement for current or chronic use of a proton pump inhibitor, H2 receptorblocker, sucralfate or misoprostol.

• Erosive esophagitis, esophageal or gastric variceal disease, or non-endoscopic gastricsurgery. Patients with a history of GERD/erosive esophagitis or dyspepsia who do notcurrently require proton pump blockers will be eligible.

• Receipt of > 21 days of clopidogrel or another thienopyridine prior to randomization.

• Oral anticoagulation that cannot be safely discontinued for duration of study.

• Recent fibrinolytic therapy.

• Scheduled percutaneous coronary intervention (PCI). Patients may be enrolled uponcompletion of PCI.

• Recent (< 30 days prior to randomization) or scheduled coronary artery bypass graft (CABG) surgery.

• Cardiogenic shock at time of randomization, refractory ventricular arrhythmias, orcongestive heart failure (NY Heart Association class IV).

• Active pathological bleeding or a history of hereditary or acquired hemostaticdisorder.

• History of hemorrhagic stroke, intracranial neoplasm, arteriovenous malformation oraneurysm.

• Systemic corticosteroids except low-dose oral corticosteroids equivalent to prednisone < or equal to 5 mg/day.

• Allergy or contraindication to clopidogrel or other thienopyridine drugs, omeprazoleor other proton pump inhibitor drugs, aspirin or salicylate derivatives, or otherstudy drug ingredients.

• Treatment within 30 days prior to randomization with any investigational drug ordevice including investigational coronary artery stents or currently enrolled inanother interventional drug or device study.

• Women who are pregnant or breastfeeding.

• Life expectancy less than 12 months.

• Laboratory abnormality at screening that is clinically significant or outsideprotocol-allowed limits, or any other condition that precludes participation in thestudy in the opinion of the Investigator.