Switching to dabigatran versus staying on apixaban/edoxaban/rivaroxaban for S. aureus bloodstream infection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• NL and Labrador Health Services- Health Sciences Centre
  St. John's, Newfoundland and Labrador, Canada Recruiting
• NL and Labrador Health Services- St. Clare's Mercy Hospital
  St. John's, Newfoundland and Labrador, Canada Recruiting
• 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: Fatima Amari
• Email: fatima.amari@rimuhc.ca
• Phone: 514-934-1934

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.