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Compares treatment options for Bleeding Post Cardiac Surgery
Official title The Direct Oral Anticoagulation Versus Vitamin K Antagonist After Cardiac Surgery Trial
ClinicalTrials.gov ID: NCT04284839
What this study is testing
What is DOAC?
DOAC is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for bleeding post cardiac surgery.
Also referred to as Apixaban, Dabigatran.
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
- The DANCE Trial is a multi-centre, randomized controlled trial comparing the safety of direct oral anticoagulants (DOAC) versus vitamin K antagonists (VKA) in the early period (30 days) after cardiac surgery in patients with atrial fibrillation requiring oral anticoagulation.
- Phase 3: a large, late-stage study
- 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
- Age ≥18 years at the time of enrolment,
- Open heart surgery in the last 10 days,
- Atrial fibrillation requiring anticoagulation (including pre-existing or post-operative atrial fibrillation),
- Informed consent from either the patient or a substitute decision-maker.
You likely can't join if
- Mechanical valve replacement,
- Antiphospholipid syndrome (triple positive),
- Severe renal failure (Cockcroft-Gault equation; creatinine clearance \<15 ml/min),
- Known significant liver disease (Child-Pugh classification B and C),
- Left ventricular thrombus,
- Ongoing bleeding, hemorrhagic disorders, or bleeding diathesis,
See the full eligibility criteria
- Age ≥18 years at the time of enrolment,
- Open heart surgery in the last 10 days,
- Atrial fibrillation requiring anticoagulation (including pre-existing or post-operative atrial fibrillation),
- Informed consent from either the patient or a substitute decision-maker.
- Mechanical valve replacement,
- Antiphospholipid syndrome (triple positive),
- Severe renal failure (Cockcroft-Gault equation; creatinine clearance \<15 ml/min),
- Known significant liver disease (Child-Pugh classification B and C),
- Left ventricular thrombus,
- Ongoing bleeding, hemorrhagic disorders, or bleeding diathesis,
- Known contraindication for any DOAC or VKA,
- Women who are pregnant, breastfeeding, or of childbearing potential,
- Surgery including left ventricular assist device implantation or cardiac transplantation,
- Previously enrolled in this trial,
- Follow-up not possible,
- History of moderate or severe mitral valvular lesion (stenosis or regurgitation) that is not corrected during index cardiac surgery.
The study team makes the final eligibility decision.
Where it's taking place
- Fitzroy, Victoria, Australia
- Parkville, Victoria, Australia
- Edmonton, Alberta, Canada
- Vancouver, British Columbia, Canada
- Winnipeg, Manitoba, Canada
- Saint John, New Brunswick, Canada
- St. John's, Newfoundland and Labrador, Canada
- Greater Sudbury, Ontario, Canada
- Hamilton, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Québec, Quebec, Canada
- Leipzig, Saxony, Germany
- Jena, Thuringia, Germany
- Bonn, Germany
- Essen, Germany
- Hamburg, Germany
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 Fitzroy, Victoria, Australia; Parkville, Victoria, Australia; Edmonton, Alberta, Canada; Vancouver, British Columbia, Canada; Winnipeg, Manitoba, Canada; Saint John, New Brunswick, Canada and 11 more location(s). 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.