N
← Back to Search
Sponsored

Accelerate Your Clinical Trial Recruitment

Reach thousands of high-intent patients matching your specific inclusion criteria.

Start Campaign
RECRUITING Phase 4 ClinicalTrials.gov

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

Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre • ClinicalTrials.gov ID: NCT06650501

Registry updated: 2026-09-24
Ad

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Check Eligibility →

Description

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.

Interventions

  • Dabigatran (Drug)
    Patients will be assigned to change to dabigatran at the monograph approved dose for their indication, bleeding risk, and renal function.
  • Apixaban (Drug)
    Patients will continue taking their currently prescribed apixaban, edoxaban, or rivaroxaban
  • edoxaban (Drug)
    Patients will continue taking their currently prescribed apixaban, edoxaban, or rivaroxaban
  • Rivaroxaban (Drug)
    Patients will continue taking their currently prescribed apixaban, edoxaban, or rivaroxaban

Eligibility 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)

Conditions

Staphylococcus Aureus Endocarditis Staphylococcus Aureus Septicemia Staphylococcus Aureus Bacteremia Staphylococcus Aureus Bloodstream Infection S. Aureus Bacteremia S. Aureus Bloodstream Infection

Locations

  • NL and Labrador Health Services- Health Sciences Centre — St. John's, Newfoundland and Labrador, Canada
  • NL and Labrador Health Services- St. Clare's Mercy Hospital — St. John's, Newfoundland and Labrador, Canada
  • McGill University Health Centre (Royal Victoria Hospital and Montreal General Hospital) — Montreal, Quebec, Canada
Sponsored

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record