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

Study acronym: SHORT RUN AF
StatusNot Yet Recruiting
PhasePhase 4
Started2023-04-05
View on ClinicalTrials.gov ↗

Amendment history

2023-03-24
minor
Study Status, Study Description v1
Primary completion date2027-02-01→2027-04-05
Completion date2027-02-01→2027-04-05
Start date2022-10-01→2023-04-05
Study description+7 characters
[...] reduction of stroke (net clinical benefit). In this study, wethe study also attempt to describe the clinical course of patients wi [...]
2022-08-02
minor
Original filing
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).
Trial Details
NCT Number NCT05487950
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Conditions Excessive Supraventricular Ectopies or Short Atrial Runs (ESVEA)
Enrollment 550 participants
Start Date 2023-04-05
Primary Completion 2027-04-05 (estimated)
Study Completion 2027-04-05 (estimated)
Updated on ClinicalTrials.gov 2023-03-28