Adjunctive dabigatran therapy improves outcome of experimental left-sided Staphylococcus aureus endocarditis.
Christian J Lerche, Lars J Christophersen, Jens Peter Goetze...
https://pubmed.ncbi.nlm.nih.gov/31002679Actively Recruiting
Phase 4
Age: 18Years +
All Genders
ID06650501
Dabigatran versus Oral Anti-Xa Inhibitors in Patients with Staphylococcus 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
N/A
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
Researchers are evaluating the use of dabigatran compared to other oral anticoagulants (apixaban, edoxaban, or rivaroxaban) in patients with Staphylococcus aureus bacteremia who are already taking these medications for approved reasons such as stroke prevention in atrial fibrillation or treatment of venous thromboembolism. This open-label randomized controlled trial is a sub-study of the Staphylococcus aureus Network Adaptive Platform (SNAP) trial and aims to determine if switching to dabigatran improves outcomes in this group. Participants will be randomly assigned to either continue their current oral anti-Xa inhibitor medication or switch to dabigatran at a dose adjusted for their approved indication, bleeding risk, and kidney function. The study compares these two strategies over a 90-day period post enrollment within the SNAP trial framework. During the study, researchers will monitor multiple outcomes including the Desirability of Outcome Ranking (DOOR) at day 90, clinical failure, adverse events leading to treatment discontinuation, mortality, infectious complications, major bleeding, thromboembolic events, stroke, and heart attacks. Participant health will be closely followed through regular assessments and safety monitoring throughout the trial duration.
CONDITIONS
Brief Title
Dabigatran vs. Oral Anti-Xa Inhibitors in S. Aureus Bacteremia
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patient is currently taking or will soon start taking an oral anti-Xa inhibitor (apixaban, edoxaban, or rivaroxaban) for stroke prevention in atrial fibrillation, treatment or prevention of deep vein thrombosis or pulmonary embolism, or prevention of venous thromboembolism after hip or knee replacement with at least 30 days of treatment remaining.
You will not qualify if you...
- Active bleeding determined by the site investigator after discussion with the treating team (may be eligible up to 120 hours if resolved and therapy resumed)
- Planned major cardiac, neurosurgery, or spine surgery within the next 3 days
- Known pregnancy (with testing for women who can become pregnant)
- Use of dabigatran within the last month
- Allergy to dabigatran
- Using certain medications such as amiodarone, ketoconazole, rifampin, verapamil, clopidogrel, prasugrel, or ticagrelor
- Severe kidney impairment with eGFR less than 30 mL/min calculated by Cockcroft-Gault equation (may be eligible up to 120 hours if acute kidney injury resolves)
- Off-label use like mechanical heart valve, left ventricular thrombus, or antiphospholipid antibody syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 90 days post enrollment
Participants receive either dabigatran or continue their current anticoagulant therapy to treat Staphylococcus aureus bacteremia.
Visits scheduled as per standard clinical care during treatment period
Trial Site Locations
Total: 1 location
1
McGill University Health Centre (Royal Victoria Hospital and Montreal General Hospital)
Montreal, Quebec, Canada, H4A3S1
Actively Recruiting
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Research Team
L
Lina Petrella
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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Published Research Related To This Trial
Dabigatran and the Risk of Staphylococcus aureus Bacteremia: A Nationwide Cohort Study.
Jawad H Butt, Emil L Fosbøl, Peter Verhamme...
https://pubmed.ncbi.nlm.nih.gov/32478836Inhibition of staphylothrombin by dabigatran reduces Staphylococcus aureus virulence.
T Vanassche, J Verhaegen, W E Peetermans...
https://pubmed.ncbi.nlm.nih.gov/22040101Dabigatran inhibits Staphylococcus aureus coagulase activity.
Thomas Vanassche, Jan Verhaegen, Willy E Peetermans...
https://pubmed.ncbi.nlm.nih.gov/20810780Targeting Coagulase Activity in Staphylococcus aureus Bacteraemia: A Randomized Controlled Single-Centre Trial of Staphylothrombin Inhibition.
Marijke Peetermans, Laurens Liesenborghs, Kathelijne Peerlinck...
https://pubmed.ncbi.nlm.nih.gov/29614521The Staphylococcus aureus Network Adaptive Platform Trial Protocol: New Tools for an Old Foe.
Steven Y C Tong, Jocelyn Mora, Asha C Bowen...
https://pubmed.ncbi.nlm.nih.gov/35717634Is there a role for anticoagulation with dabigatran in S. aureus bacteremia? Protocol for the adjunctive treatment domain of the Staphylococcus aureus Network Adaptive Platform (SNAP) randomised controlled trial.
Emily G McDonald, Matthew P Cheng, Joshua S Davis...
https://pubmed.ncbi.nlm.nih.gov/41387009