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

NCT05487950 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 550

Last updated 2023-03-28

No results posted yet for this study

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).

Conditions

  • Excessive Supraventricular Ectopies or Short Atrial Runs (ESVEA)

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).

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05487950 on ClinicalTrials.gov