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

Exclusion Criteria

• •Patients currently hospitalized for whom discharge is not anticipated within 48 hours of randomization.
• •Requirement for current or chronic use of a proton pump inhibitor, H2 receptor blocker, sucralfate or misoprostol.
• •Erosive esophagitis, esophageal or gastric variceal disease, or non-endoscopic gastric surgery. Patients with a history of GERD/erosive esophagitis or dyspepsia who do not currently 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 upon completion 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, or congestive heart failure (NY Heart Association class IV).
• •Active pathological bleeding or a history of hereditary or acquired hemostatic disorder.
• •History of hemorrhagic stroke, intracranial neoplasm, arteriovenous malformation or aneurysm.
• •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, omeprazole or other proton pump inhibitor drugs, aspirin or salicylate derivatives, or other study drug ingredients.
• •Treatment within 30 days prior to randomization with any investigational drug or device including investigational coronary artery stents or currently enrolled in another 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 outside protocol-allowed limits, or any other condition that precludes participation in the study in the opinion of the Investigator.