Study Design and Participants
bleeding, gastrointestinal ulcers, erosions, gastrointestinal tract, GIB, coronary artery disease, peptic ulcer
RECRUITMENT, BLEEDING, GASTROINTESTINAL ULCERS, ULCERS, KIDNEY DYSFUNCTION, ACUTE CORONARY SYNDROMES, SECONDARY, EVENTS, CORONARY ARTERY DISEASE, PEPTIC ULCER
This study is a secondary analysis of the OPT-PEACE double-masked, placebo-controlled, multicenter randomized clinical trial conducted at 28 centers in China.The OPT-PEACE trial enrolled patients with stable coronary artery disease or acute coronary syndromes without ST-segment elevation after PCI. Recruitment occurred between July 13, 2017, and July 13, 2019. Patients aged 18 to 80 years who planned to use DAPT for at least 6 months were included. Patients with high GIB risk, including those with a history of GIB or peptic ulcer within 24 months, prior gastrointestinal tract or abdominal surgery, kidney dysfunction, or requirement for chronic oral anticoagulation were excluded. A baseline MCE was performed, and patients were excluded if ulcers or bleeding were found. After 6 months of DAPT, patients without overt bleeding or ischemic events underwent a second MCE. Eligible patients without gastrointestinal ulcers or GIB (erosions were permitted) on the first 2 MCEs (ie, the intention-to-treat [ITT] population) were then randomly assigned (1:1:1) to receive enteric-coated aspirin (100 mg/d) plus matching clopidogrel placebo (aspirin alone), clopidogrel (75 mg/d) plus matching aspirin placebo (clopidogrel alone), or aspirin plus clopidogrel (DAPT) for the next 6 months. A third MCE was performed 6 months after randomization (12 months after PCI). A 