Comparing Oral Factor Xa Inhibitor and Vitamin K Antagonist Treatments for Long-Term Use After Mechanical Aortic Valve Replacement

What this Trial Is About

Researchers are evaluating the long-term use of oral factor Xa inhibitors compared to vitamin K antagonists in patients who have undergone mechanical aortic valve replacement. This study focuses on how these treatments affect the risk of cardiac death, valve thrombosis, thromboembolic events, and bleeding complications. The trial is conducted as a randomized Phase 4 treatment study. Participants will receive either Rivaroxaban, an oral factor Xa inhibitor, or a vitamin K antagonist warfarin for 12 months. Rivaroxaban is given as a 20mg oral tablet once daily, with a reduced dose of 15mg for certain kidney conditions. The vitamin K antagonist group will maintain a specific blood clotting range INR 1.7-3.0 throughout the treatment period. Throughout the study, participants will be monitored for events such as cardiac death, valve thrombosis, stroke, bleeding, and other cardiovascular events using various diagnostic tools. The primary outcome is measured at 1 year, and the study includes detailed recording of secondary outcomes like changes in echocardiographic parameters. Safety and treatment effectiveness will be regularly assessed during this period.

Long-term Anticoagulation With Oral Factor Xa Inhibitor Versus Vitamin K Antagonist After Mechanical Aortic Valve Replacement