drugset / Trial / NCT05487950

Rivaroxaban Versus Standard of Care for Patients With Excessive Atrial Ectopy or Short Atrial Runs and High Embolism Risk

NCT05487950

Phase 4 Not yet recruiting 550 enrolled Assistance Publique - Hôpitaux de Paris
RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of the Short Run AF study is to evaluate the efficacy and safety of long term anticoagulation with rivaroxaban against standard of care (SOC) in patients with ESVEA and CHA2DS2VASC score ≥3 on the incidence of ischemic stroke and peripheral embolism after 2 years follow-up and the occurrence of major bleeding events. The primary efficacy endpoint is the first ischemic stroke or peripheral embolism detected clinically and on systematic cerebral MRIs in a time-to-event analysis. The primary safety outcome is major bleeding at any site in the body according to the criteria of the International Society of Thrombosis and Hemostasis (ISTH)(23-25).

Timeline

Start
2023-04-05
Primary completion
2027-04-05
Completion
2027-04-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Rivaroxaban Other / unclassified 10 mg
Subject Rivaroxaban Other / unclassified 15 mg