Proton pump inhibitor in the prevention of upper gastrointestinal mucosal injury associated with dual antiplatelet therapy after coronary artery bypass grafting (DACAB-GI-2): study protocol for a randomized controlled trial

Background: Dual antiplatelet therapy (DAPT) is recommended in secondary prevention after coronary artery bypass grafting (CABG), but it is inevitably associated with the risk of bleeding, of which gastrointestinal bleeding accounts for more than half. Proton pump inhibitors (PPIs) may increase the risk of major cardiovascular adverse events when reducing the risk of upper gastrointestinal bleeding. Therefore, the optimal duration of a PPI in combination with DAPT is unclear.

Methods: The "Proton Pump Inhibitor Preventing Upper Gastrointestinal Injury in Patients on Dual Antiplatelet Therapy after CABG" (DACAB-GI-2) study is a prospective, single-center, open-label, parallel, randomized controlled trial. A total of 232 eligible subjects who are scheduled or initiated on DAPT (clopidogrel plus aspirin or ticagrelor plus aspirin) for 12 months immediately after CABG will be enrolled and be randomized in a 1:1 ratio to either a 12-month pantoprazole treatment arm or a 1-month treatment arm. The primary outcome is to assess the rate of gastroduodenal erosions and ulcers evaluated by esophagogastroduodenoscopy (EGD) within 12 months after randomization, based on the modified Lanza score. Secondary outcomes include reflux esophagitis and upper gastrointestinal bleeding. Other pre-specified outcomes include major adverse cardiovascular events, graft failure, and all-cause death.

Discussion: This study aims to compare the efficacy and safety of 12 months and 1 month of pantoprazole treatment in preventing DAPT-related upper gastrointestinal mucosal injury after CABG.

Trial registration: ClinicalTrials.gov NCT03908593 .