Rivaroxaban and Aspirin Versus Aspirin Alone in Preventing Atherothrombotic Events in Patients Following Coronary Artery Bypass Graft Surgery

IR.SUMS.MED.REC.1401.411

Post coronary bypass patients were randomized to receiving aspirin alone or aspirin and low dose rivaroxaban

2021-02-01

2022-05-01

2022-07-20

Completed

Early phase I

234

Inclusion Criteria: * Patients older than 18 undergoing primary isolated coronary bypass surgery, with or without cardiopulmonary bypass Exclusion Criteria: * Other cardiac surgeries except for coronary bypass surgery * Left ventricular ejection fraction \< 30 % * Liver disease * Clopidogrel or aspirin intake within 7 days of operation * Need for perioperative warfarin * Active gastroduodenal ulcer or post-operative gastrointestinal bleeding * Profuse post-operative pleural effusion (drainage \>200 ml/h for 2 h or more * Postoperative low cardiac output syndrome or requirement for high levels of hemodynamic support (more than 2 inotropes for more than 24 h and/or intra-aortic balloon pump) * Clinical instability, such as perioperative myocardial infarction or malignant tumor.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized double blind of placebo and intervention group', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'simple randomization', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 234, 'type': 'ACTUAL'}}

2023-09-06