Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Cogentus Pharmaceuticals
Age
21–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients in whom a requirement for clopidogrel therapy with concomitant aspirin is anticipated for at least the next 12 months. Specific conditions that may confer a need for long-term clopidogrel + aspirin therapy may include non-ST segment elevation acute coronary syndrome (unstable angina/non-Q-wave MI), ST segment elevation acute MI), or new placement of a coronary artery stent.
For women of childbearing potential, negative pregnancy test prior to randomization and agreement to use effective method of birth control during the study.
Able to provide written informed consent based on competent mental status.
You may not be if
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.
