Actively Recruiting
Dabigatran vs. Oral Anti-Xa Inhibitors in S. Aureus Bacteremia
Led by McGill University Health Centre/Research Institute of the McGill University Health Centre · Updated on 2026-03-20
300
Participants Needed
1
Research Sites
206 weeks
Total Duration
On this page
Sponsors
M
McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead Sponsor
U
University of Melbourne
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Dabigatran vs. Oral Anti-Xa Inhibitors in S. Aureus Bacteremia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is taking or will soon start taking an oral Xa inhibitor (apixaban, edoxaban, or rivaroxaban) for stroke prevention in atrial fibrillation, treatment or secondary prevention of deep venous thrombosis or pulmonary embolism, or prevention of venous thromboembolism after hip or knee replacement surgery with at least 30 days of treatment remaining
- Participant meets all inclusion and exclusion criteria for the SNAP Platform trial (NCT05137119)
You will not qualify if you...
- Active bleeding as determined by the site investigator after discussion with the treating team (may remain eligible if resolved within 120 hours and antithrombotic therapy is resumed)
- Planned major cardiac, neurosurgery, or spine surgery within the next 3 days
- Known pregnancy
- Known use of dabigatran within the last month
- Allergy to dabigatran
- Concurrent use of amiodarone, ketoconazole, rifampin, verapamil, clopidogrel, prasugrel, or ticagrelor
- Estimated glomerular filtration rate (eGFR) less than 30 mL/minute calculated by Cockcroft-Gault equation (may remain eligible if acute kidney injury resolves within 120 hours and therapy can be safely resumed)
- Off-label use such as mechanical heart valve, left ventricular thrombus, or antiphospholipid antibody syndrome
AI-Screening
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Trial Site Locations
Total: 1 location
1
McGill University Health Centre (Royal Victoria Hospital and Montreal General Hospital)
Montreal, Quebec, Canada, H4A3S1
Actively Recruiting
Research Team
L
Lina Petrella
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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