6/28/23, 12:13 AM COGENT Pathway Feedback Search Clinical Topics Home Studies COGENT COGENT Disease Disease Disease Acute ischemic stroke Coronary artery disease Periphe Trial question What is the role of prophylactic omeprazole among patients with an indication for dual antiplatelet therapy (aspirin and clopidogrel)? Study design Multi-center Double blinded RCT Population Characteristics of study participants 32.0% female N = 3873 68.0% male 3873 patients (1196 female, 2563 male) Inclusion criteria: patients with an indication for dual antiplatelet therapy Key exclusion criteria: short-term or long-term use of a PPI, an H2-receptor antagonist, sucralfate, or misoprostol; preexisting erosive esophagitis or esophageal or gastric variceal disease or previous nonendoscopic gastric surgery; receipt of clopidogrel or another thienopyridine for > 21 days before randomization; or recent fibrinolytic therapy Interventions N=1876 omeprazole (omeprazole 20 mg plus clopidogrel 75 mg and aspirin 75-325 mg daily) N=1885 placebo (clopidogrel 75 mg and aspirin 75-325 mg daily) Primary outcome Overt or occult bleeding, symptomatic gastroduodenal ulcers or erosions, obstruction, or perforation https://web.pathway.md/studies/recNDZKIDnEYHzp70 1/2 6/28/23, 12:13 AM COGENT Pathway 2.9 % 2.9 2.2 % 1.4 % Significant decrease 1.1 0.7 % NNT = 56 0.0 % Omeprazole Placebo Significant decrease in overt or occult bleeding, symptomatic gastroduodenal ulcers or erosions, obstruction, or perforation (1.1% vs. 2.9%; HR 0.34, 95% CI 0.18 to 0.63) Secondary outcomes Significant decrease in overt upper gastrointestinal bleeding (0.2% vs. 1.2%; HR 0.13, 95% CI 0.03 to 0.56) No significant difference in cardiovascular event (4.9% vs. 5.7%; HR 0.99, 99% CI 0.68 to 1.44) Safety outcomes No significant differences in rate of serious adverse events (10.1% vs. 9.4%, p=0.48) and overall adverse events (41.3% vs. 42.8%, p=0.33). Significant differences in risk of diarrhea (3.0% vs. 1.8%, p = 0.01). Conclusion In patients with an indication for dual antiplatelet therapy, omeprazole was superior to placebo with respect to overt or occult bleeding, symptomatic gastroduodenal ulcers or erosions, obstruction, or perforation. Reference Bhatt DL, Cryer BL, Contant CF et al. Clopidogrel with or without omeprazole in coronary artery disease. N Engl J Med. 2010 Nov 11;363(20):1909-17. Open reference URL https://web.pathway.md/studies/recNDZKIDnEYHzp70 2/2