Study of Century Clot-Guided Low-Dose Rivaroxaban Added to Standard Antiplatelet Therapy to Prevent Left Ventricular Thrombus After Anterior STEMI Compared to Standard Dual Antiplatelet Therapy Alone

What this Trial Is About

The trial focuses on patients who have experienced ST-segment elevation myocardial infarction STEMI, especially those with anterior STEMI, which can lead to left ventricular thrombus LVT formation. Researchers are studying whether adding low-dose rivaroxaban guided by the Century Clot analyzer to standard dual antiplatelet therapy DAPT can effectively prevent LVT without increasing major bleeding risks. This Phase 4 study addresses the challenge of balancing bleeding and clotting risks in post-STEMI treatment where evidence is limited. Participants will receive standard DAPT aspirin plus ticagrelor or clopidogrel after primary percutaneous coronary intervention PCI. They are randomly assigned within 12 to 24 hours post-PCI to either a group receiving additional rivaroxaban 2.5 mg twice daily for one month if identified as hypercoagulable by the Century Clot test, or a control group receiving standard DAPT alone. After the first month, rivaroxaban is stopped, and both groups continue with a reduced ticagrelor dose or clopidogrel plus aspirin for 11 months. Throughout the study, participants will be monitored for LVT formation and bleeding events at one month, with additional follow-up at 12 months to assess net adverse clinical events including cardiac death, heart attacks, revascularization, stroke, and major bleeding. The study involves clinical assessments, blood tests, and imaging to evaluate outcomes, aiming to optimize antithrombotic therapy after STEMI while ensuring safety over a year-long period.

Century Clot-Guided Prophylactic Rivaroxaban for Post STEMI Complicating Left Ventricular Thrombus