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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patient is taking (or will imminently start taking) an oral Xa inhibitor (e.g., apixaban, edoxaban, rivaroxaban) for: stroke prevention in atrial fibrillation, treatment or secondary prevention of deep venous thrombosis or pulmonary embolism, prevention of VTE in patients who have undergone elective total hip or total knee replacement surgery provided there are 30 or more days of planned treatment remaining at the time of enrolment.

Locations
Other Locations
Canada
McGill University Health Centre (Royal Victoria Hospital and Montreal General Hospital)
RECRUITING
Montreal
Contact Information
Primary
Lina Petrella
lina.petrella@muhc.mcgill.ca
514-934-1934
Time Frame
Start Date: 2026-01-15
Estimated Completion Date: 2030-01
Participants
Target number of participants: 300
Treatments
Experimental: Change to Dabigatran
Patients will have their anticoagulation changed to dabigatran at the monograph approved dose for the indication, bleeding risk, and renal function.
Active_comparator: Continue current anticoagulant
Patients will continue their currently prescribed apixaban, edoxaban, or rivaroxaban
Sponsors
Leads: McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators: University of Melbourne

This content was sourced from clinicaltrials.gov

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