Recruiting

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

Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Code:

NCT06650501

Conditions

Staphylococcus Aureus Endocarditis

Staphylococcus Aureus Septicemia

Staphylococcus Aureus Bacteremia

Staphylococcus Aureus Bloodstream Infection

S. Aureus Bacteremia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dabigatran

Apixaban

edoxaban

Rivaroxaban

Study Details

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.

Conditions

Staphylococcus Aureus Endocarditis

Staphylococcus Aureus Septicemia

Staphylococcus Aureus Bacteremia

Staphylococcus Aureus Bloodstream Infection

S. Aureus Bacteremia

Study ID

NCT06650501

Start date

Jan 15, 2026

Status verified date

Jan, 2026

Completion date

Jan, 2030

Anticipated

Primary completion date

Jan, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Change to Dabigatran

Patients will have their anticoagulation changed to dabigatran at the monograph approved dose for the indication, bleeding risk, and renal function.

active comparator: Continue current anticoagulant

Patients will continue their currently prescribed apixaban, edoxaban, or rivaroxaban

Interventions

Dabigatran

Patients will be assigned to change to dabigatran at the monograph approved dose for their indication, bleeding risk, and renal function.

Apixaban

Patients will continue taking their currently prescribed apixaban, edoxaban, or rivaroxaban

edoxaban

Patients will continue taking their currently prescribed apixaban, edoxaban, or rivaroxaban

Rivaroxaban

Patients will continue taking their currently prescribed apixaban, edoxaban, or rivaroxaban

Primary outcome measure

Desirability of Outcome Ranking (DOOR) [ Time Frame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119) ]

Central Contacts and Locations

Central contacts

Lina Petrella

514-934-1934 lina.petrella@muhc.mcgill.ca

Locations

McGill University Health Centre (Royal Victoria Hospital and Montreal General Hospital)

Recruiting

Montreal, Quebec, Canada, H4A3S1

Contacts

Lina Petrella

514-934-1934 lina.petrella@muhc.mcgill.ca

Principal Investigator:

Emily G McDonald, MD MSc

More Information

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Last update posted

Mar 20, 2026

Last verified

Jan, 2026

Keywords

S. aureus bacteremia
S. aureus bloodstream infection
S. aureus endocarditis
Dabigatran
Edoxaban
Rivaroxaban
Apixaban

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2026-03-20.