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NOT YET RECRUITING
NCT05487950
PHASE4

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

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

550

Start Date

2023-04-05

Completion Date

2027-04-05

Last Updated

2023-03-28

Healthy Volunteers

No

Interventions

DRUG

Rivaroxaban group

Patients assigned in the Rivaroxaban group will receive 15 mg once day or 10 mg if dosage modification is needed due to renal insufficiency (Creatinine clairance calculated with the Cockroft formula between 30 or 49 ml/min).