Switching to dabigatran versus staying on apixaban/edoxaban/rivaroxaban for S. aureus bloodstream infection
Dabigatran vs. Oral Anti-Xa Inhibitors in S. Aureus Bacteremia
This trial will try whether switching people with S. aureus bloodstream infection who are already taking apixaban, edoxaban, or rivaroxaban to dabigatran leads to better outcomes.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT06650501 on ClinicalTrials.gov |
What this trial studies
This open-label, randomized phase 4 substudy within the SNAP platform enrolls patients with S. aureus bacteremia who are already taking an oral factor Xa inhibitor and randomizes them to continue their current drug or change to dabigatran. Participants continue anticoagulation for their original indication while investigators follow clinical outcomes related to the bloodstream infection. Dabigatran has shown antimicrobial activity against S. aureus in laboratory and animal studies and signaled benefit in a smaller randomized trial, which motivates testing it in this specific patient group. The trial is led by McGill University Health Centre with collaboration from the University of Melbourne and is conducted at participating SNAP centers in Montreal.
Who should consider this trial
Good fit: Ideal candidates are adults with confirmed S. aureus bacteremia who are taking (or will imminently start) an oral factor Xa inhibitor for atrial fibrillation or treatment/prevention of venous thromboembolism and who meet the SNAP platform eligibility criteria.
Not a fit: Patients not on oral Xa inhibitors, those with active bleeding, known pregnancy, or those needing imminent major cardiac, neurosurgical, or spine surgery are unlikely to benefit or may be excluded.
Why it matters
Potential benefit: If successful, switching to dabigatran could reduce complications or death from S. aureus bloodstream infections in patients who require oral anticoagulation.
How similar studies have performed: Laboratory and animal studies and a smaller randomized trial have suggested anti–S. aureus activity and possible clinical benefit with dabigatran, but large-scale clinical confirmation is lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
The participant must meet all inclusion and exclusion criteria for the SNAP Platform (NCT05137119) and also the following inclusion and exclusion criteria: Inclusion Criteria: * 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. Exclusion Criteria: * Active bleeding as determine by the site investigator after discussion with the treating team (patient may remain eligible for up to 120 hours from platform entry if condition is resolved and antithrombotic therapy is resumed) * Anticipated major cardiac surgery, neurosurgery, or spine surgery within the next 3 days * Known pregnancy (with testing available for women with childbearing potential) * Known use of dabigatran within last month * Allergy to dabigatran * Concomitant use of amiodarone, ketoconazole, rifampin, verapamil, clopidogrel, prasugrel, or ticagrelor * eGFR \< 30mL/minute calculated by Cockcroft-Gault equation using adjusted weight \[patient may remain eligible for up to 120 hours from platform entry if acute kidney injury is resolved such that antithrombotic therapy can be safely resumed/prescribed\] * Off label use (e.g., metallic mechanical heart valve, left ventricular thrombus, antiphospholipid antibody syndrome)
Where this trial is running
Montreal, Quebec
- McGill University Health Centre (Royal Victoria Hospital and Montreal General Hospital) — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Emily G McDonald, MD MSC — Research Institute of the McGill University Health Centre
- Study coordinator: Lina Petrella
- Email: lina.petrella@muhc.mcgill.ca
- Phone: 514-934-1934
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.