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RECRUITING
NCT06650501
PHASE4

Dabigatran vs. Oral Anti-Xa Inhibitors in S. Aureus Bacteremia

Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

View on ClinicalTrials.gov

Summary

This is an open-label randomized controlled trial which will enroll patients with S. aureus bacteremia who are already taking oral anticoagulant medications (apixaban, edoxaban, or rivaroxaban) for an approved indication (stroke prevention in atrial fibrillation, prevention or treatment of venous thromboembolism). We will randomize patients to continue their existing medication or change to another medication (dabigatran) which is approved for the original indication. Dabigatran is approved in many countries for the treatment or prevention of venous thromboembolism or preventing stroke in atrial fibrillation. Unlike the other medications listed above, dabigatran seems to have activity against S. aureus in the test tube, in animal models, and in a smaller randomized controlled trial. We wish to determine if changing to dabigatran will improve outcomes in S. aureus bacteremia in people who otherwise would have a reason to be taking it. This study is an approved sub-study of The Staphylococcus aureus Network Adaptive Platform (SNAP) trial (NCT05137119). If positive, this study will support a second RCT in people who do not currently have an indication for anticoagulation.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2026-01-15

Completion Date

2030-01

Last Updated

2026-03-20

Healthy Volunteers

No

Interventions

DRUG

Dabigatran

Patients will be assigned to change to dabigatran at the monograph approved dose for their indication, bleeding risk, and renal function.

DRUG

Apixaban

Patients will continue taking their currently prescribed apixaban, edoxaban, or rivaroxaban

DRUG

edoxaban

Patients will continue taking their currently prescribed apixaban, edoxaban, or rivaroxaban

DRUG

Rivaroxaban

Patients will continue taking their currently prescribed apixaban, edoxaban, or rivaroxaban

Locations (1)

McGill University Health Centre (Royal Victoria Hospital and Montreal General Hospital)

Montreal, Quebec, Canada