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Staphylococcus Aureus EndocarditisPhase 4DABI-SNAPNCT06650501

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

A Phase 4 study testing Dabigatran, Apixaban and edoxaban in people with Staphylococcus Aureus Endocarditis and Staphylococcus Aureus Septicemia, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 3 sites in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Dabigatran, Apixaban and edoxaban
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
3 sitesCanada
Study dates
15 Jan 2026to Jan 2030
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Fatima Amari contact

514-934-1934 ext. 23730

fatima.amari@rimuhc.ca

Canada3 sites, 3 recruiting

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

    Montreal, Quebec, H4A3S1

    Fatima Amari, 514-934-1934 ext. 23730, fatima.amari@rimuhc.ca

    Emily G McDonald, MD MSc

    Recruiting

  • NL and Labrador Health Services- Health Sciences Centre

    St. John's, Newfoundland and Labrador, A1B 3V6

    Peter Daley, MD, Peter.Daley@easternhealth.ca

    Peter Daley, MD

    Recruiting

  • NL and Labrador Health Services- St. Clare's Mercy Hospital

    St. John's, Newfoundland and Labrador, NL A1C 5B8

    Peter Daley, MD, Peter.Daley@easternhealth.ca

    Peter Daley, MD

    Recruiting

Other trials in Canada

About this study

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.

Read more

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.

Being tested
Dabigatran, Apixaban, edoxaban, Rivaroxaban
Keywords
S. aureus bacteremia, S. aureus bloodstream infection, S. aureus endocarditis, Dabigatran, Edoxaban, Rivaroxaban, Apixaban

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DabigatranDrug

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

  • ApixabanDrug

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

  • edoxabanDrug

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

  • RivaroxabanDrug

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

Study groups in NCT06650501
Study groupRoleWhat they receive
Change to DabigatranExperimentalPatients will have their anticoagulation changed to dabigatran at the monograph approved dose for the indication, bleeding risk, and renal function.
Receives: Drug: Dabigatran
Continue current anticoagulantActive comparatorPatients will continue their currently prescribed apixaban, edoxaban, or rivaroxaban
Receives: Drug: Apixaban; Drug: edoxaban; Drug: Rivaroxaban

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Desirability of Outcome Ranking (DOOR)

    Desirability of Outcome Ranking (DOOR) - an ordinal outcome with 5 levels defined:

    Rank 1 - Alive without complication Rank 2 - Alive with 1 complication Rank 3 - Alive with 2 complications Rank 4 - Alive with 3 complications Rank 5 - Dead

    Complications include:

    1. Clinical failure: Absence of resolution of clinical signs and symptoms of S. aureus bacteremia such that no additional antibiotic therapy is required or anticipated.
    2. Infectious Complications: Including new endocarditis; new evidence of other deep metastatic foci (e.g., osteomyelitis or deep abscess); relapse of MRSA bacteremia after a patient has sterilized their initial blood cultures; readmission for subsequent care of S. aureus bacteremia; need for unplanned source control procedures
    3. Serious adverse drug event (Common Terminology Criteria class 4) due to study drug OR adverse drug event (classes 1-3) leading to discontinuation of the study drug

    Measured: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)

Secondary outcomes (9)

  1. Clinical failure

    Defined as the absence of resolution of clinical signs and symptoms of S. aureus bacteremia such that no additional antibiotic therapy is required or anticipated for its treatment.

    Measured: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)

  2. Serious Adverse Event or Adverse Event Leading to Discontinuation

    Defined as a serious adverse drug event (Common Terminology Criteria for Adverse Events (CTCAE) class 4) presumed due to study drug OR adverse drug event (CTCAE classes 1-3) leading to discontinuation of the study drug

    Measured: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)

  3. All cause mortality

    Death from any cause

    Measured: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)

  4. Infectious Complications

    Defined as change in therapy for inadequate clinical response; new endocarditis; new evidence of other deep metastatic foci (e.g., osteomyelitis or deep abscess); relapse of MRSA bacteremia after a patient has sterilized their initial blood cultures; readmission for subsequent care of S. aureus bacteremia; need for unplanned source control procedures. New implies that the complication was not suspected at enrollment and is not a function of delay to diagnostic testing.

    Measured: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)

  5. Clinically relevant major bleeding

    This will be defined according to the criteria of the International Society on Thrombosis and Haemostasis as one or more of the following: fatal bleeding; symptomatic bleeding in a critical area or organ (including hemorrhagic stroke); bleeding that causes a fall in hemoglobin level of ≥20 g/L; or bleeding that requires a transfusion of 2 or more units of whole blood or red cells. For bleeds into non-critical areas, we will also record the site of bleeding.

    Measured: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)

  6. Clinically relevant venous thromboembolic events

    This will be defined as an acute objectively confirmed deep vein thrombosis (upper extremity, lower extremity, other such as portal vein, cerebral vein, splanchnic vein) and/or segment or proximal pulmonary embolism, which is symptomatic and/or necessitates specific treatment. Below knee DVT and superficial thrombophlebitis are not included. Pulmonary embolism needs to be, segmental or proximal. Subsegmental pulmonary embolisms are not included as they have poor interrater reliability and may represent artefact in up to 50% of cases.

    Measured: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)

  7. Clinically relevant stroke

    Stroke is defined as the acute onset of focal neurological dysfunction caused by brain, spinal cord, or retinal vascular injury because of infarction (ischemia). Ideally, at least one of the following should be present to confirm the diagnosis of stroke: confirmation by neurology, stroke specialist, or neurosurgical specialist, brain imaging (e.g., CT scan, MRI scan, or cerebral vessel angiography compatible with acute ischemia). If the acute focal signs represent a worsening of a previous deficit, these signs must persist for more than 24 hours and be accompanied by an appropriate new MRI or CT scan finding. In the absence of neuroimaging, a staff neurologist consult which makes the diagnosis of stroke will be considered.

    Measured: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)

  8. Clinically relevant acute myocardial infarction

    Patients with S. aureus bacteremia often have substantial physiological stresses which can be associated with rises in cardiac troponin (demand ischemia). For the purposes of this outcome, acute myocardial infarction is captured as a type 1 myocardial infarction: detection of rise and/or fall of cardiac biomarkers with at least one value above the 99th percentile of the upper reference limit together with evidence of myocardial ischemia. For the purposes of this pragmatic trial, such a myocardial infarction will be inferred from the opinions of the staff cardiologist, intensivist, or general internal medicine specialist. The peak troponin value will be recorded, and a redacted copy of the relevant consultant's note and ECGs will be uploaded for audit.

    Measured: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)

  9. Clinically relevant arterial thromboembolic event

    Clinical history compatible with sudden worsening of end organ or limb perfusion and confirmation by imaging (e.g., CT angiography, arterial doppler) or need for urgent surgery or thrombolysis.

    Measured: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2024
  2. Study start15 Jan 2026
  3. Primary completionJan 2030 (estimated)
  4. Study completionJan 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06650501
Sponsor's protocol ID
2025-10900
Other IDs
500464, 2025
Acronym
DABI-SNAP
Status last verified
Sep 2026
First submitted
18 Oct 2024
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: This statement supersedes any such statement in NCT05137119. For DABI-SNAP, we will provide deidentified individual patient data required to replicate the main manuscript's tables and analyses.

Publications

  • Lerche CJ, Christophersen LJ, Goetze JP, Nielsen PR, Thomsen K, Enevold C, Hoiby N, Jensen PO, Bundgaard H, Moser C. Adjunctive dabigatran therapy improves outcome of experimental left-sided Staphylococcus aureus endocarditis. PLoS One. 2019 Apr 19;14(4):e0215333. doi: 10.1371/journal.pone.0215333. eCollection 2019.

    PubMed 31002679

  • Butt JH, Fosbol EL, Verhamme P, Gerds TA, Iversen K, Bundgaard H, Bruun NE, Larsen AR, Petersen A, Andersen PS, Skov RL, Gislason GH, Torp-Pedersen C, Kober L, Olesen JB. Dabigatran and the Risk of Staphylococcus aureus Bacteremia: A Nationwide Cohort Study. Clin Infect Dis. 2021 Aug 2;73(3):480-486. doi: 10.1093/cid/ciaa661.

    PubMed 32478836

  • Vanassche T, Verhaegen J, Peetermans WE, VAN Ryn J, Cheng A, Schneewind O, Hoylaerts MF, Verhamme P. Inhibition of staphylothrombin by dabigatran reduces Staphylococcus aureus virulence. J Thromb Haemost. 2011 Dec;9(12):2436-46. doi: 10.1111/j.1538-7836.2011.04529.x.

    PubMed 22040101

  • Vanassche T, Verhaegen J, Peetermans WE, Hoylaerts MF, Verhamme P. Dabigatran inhibits Staphylococcus aureus coagulase activity. J Clin Microbiol. 2010 Nov;48(11):4248-50. doi: 10.1128/JCM.00896-10. Epub 2010 Sep 1.

    PubMed 20810780

  • Peetermans M, Liesenborghs L, Peerlinck K, Wijngaerden EV, Gheysens O, Goffin KE, Hoylaerts MF, Jacquemin M, Verhaegen J, Peetermans WE, Verhamme P, Vanassche T; Staphylothrombin Investigators. Targeting Coagulase Activity in Staphylococcus aureus Bacteraemia: A Randomized Controlled Single-Centre Trial of Staphylothrombin Inhibition. Thromb Haemost. 2018 May;118(5):818-829. doi: 10.1055/s-0038-1639586. Epub 2018 Apr 3.

    PubMed 29614521

  • Tong SYC, Mora J, Bowen AC, Cheng MP, Daneman N, Goodman AL, Heriot GS, Lee TC, Lewis RJ, Lye DC, Mahar RK, Marsh J, McGlothlin A, McQuilten Z, Morpeth SC, Paterson DL, Price DJ, Roberts JA, Robinson JO, van Hal SJ, Walls G, Webb SA, Whiteway L, Yahav D, Davis JS; Staphylococcus aureus Network Adaptive Platform (SNAP) Study Group. The Staphylococcus aureus Network Adaptive Platform Trial Protocol: New Tools for an Old Foe. Clin Infect Dis. 2022 Nov 30;75(11):2027-2034. doi: 10.1093/cid/ciac476.

    PubMed 35717634

  • McDonald EG, Cheng MP, Davis JS, Goodman AL, Lawler PR, Marsh J, Mertz D, Paul M, Rodriguez-Bano J, Siegal DM, Tong SY, Walls G, Lee TC; SNAP Global Trial Steering Committee. Is 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. BMJ Open. 2025 Dec 12;15(12):e107493. doi: 10.1136/bmjopen-2025-107493.

    PubMed 41387009

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dabigatran, Apixaban and edoxaban in people with Staphylococcus Aureus Endocarditis and Staphylococcus Aureus Septicemia, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 3 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Fatima Amari (514-934-1934 ext. 23730, fatima.amari@rimuhc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Desirability of Outcome Ranking (DOOR) (time frame: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06650501, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.

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