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Life sciences · Phase 4 Trial
ClinicalTrials.gov · September 24, 2026
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Phase 4 Trial.
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Registry record from ClinicalTrials.gov (NCT06650501). This is a study registration, not published results. Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre. Recruitment status: RECRUITING. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 300 participants (ESTIMATED). Conditions: Staphylococcus Aureus Endocarditis, Staphylococcus Aureus Septicemia, Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Bloodstream Infection, S. Aureus Bacteremia, S. Aureus Bloodstream Infection. Interventions: DRUG: Dabigatran; DRUG: Apixaban; DRUG: edoxaban; DRUG: Rivaroxaban. Primary outcome measures: Desirability of Outcome Ranking (DOOR) , Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119). Brief 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.