drugset / Trial / NCT03926156

RIvoraxaban in Mitral Stenosis

NCT03926156

RandomizedParallel-groupSingle-blindTreatment

Summary

In this randomized controlled clinical trial, patients with moderate to severe mitral valve stenosis (MS) and atrial fibrillation (AF) will be enrolled into the study.Participants will be divided into two groups based on the anticoagulation regimen type. The intervention group will receive rivaroxaban and the control group will be given warfarin. All patients will be observed closely during a period of one year. Through the follow up, embolic events and hemorrhagic complications will be recorded in both groups. In addition, patients in both group will undergo a baseline magnetic resonance imaging (MRI) and an MRI after one-year follow up, by which the silent embolic events will be compared in both groups.

Timeline

Start
2019-05-22
Primary completion
2021-05-22
Completion
2021-08-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Rivaroxaban Other / unclassified 20 mg Oral
Comparator Warfarin Small molecule Oral