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New treatment option for Staphylococcus Aureus Endocarditis
Official title Dabigatran vs. Oral Anti-Xa Inhibitors in S. Aureus Bacteremia
ClinicalTrials.gov ID: NCT06650501
What this study is testing
What is Dabigatran?
Dabigatran is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for staphylococcus aureus endocarditis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The participant must meet all inclusion and
You likely can't join if
- 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...
- Active bleeding as determine by the site investigator after discussion with the treating team (patient may remain eligible for up to 120 hours from...
- 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
See the full eligibility criteria
- The participant must meet all inclusion and
- 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...
- 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...
- 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...
- Off label use (e.g., metallic mechanical heart valve, left ventricular thrombus, antiphospholipid antibody syndrome)
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.