The Direct Oral Anticoagulation Versus Vitamin K Antagonist After Cardiac Surgery Trial
Bleeding Post Cardiac Surgery | Indication for AnticoagulationThe 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.
null
Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 and up
Participation Criteria
Inclusion Criteria:
1. Age ≥18 years at the time of enrolment,
2. Open heart surgery in the last 10 days,
3. Atrial fibrillation requiring anticoagulation (including pre-existing or post-operative atrial fibrillation),
4. Informed consent from either the patient or a substitute decision-maker.
Exclusion Criteria:
1. Mechanical valve replacement,
2. Antiphospholipid syndrome (triple positive),
3. Severe renal failure (Cockcroft-Gault equation; creatinine clearance \<15 ml/min),
4. Known significant liver disease (Child-Pugh classification B and C),
5. Left ventricular thrombus,
6. Ongoing bleeding, hemorrhagic disorders, or bleeding diathesis,
7. Known contraindication for any DOAC or VKA,
8. Women who are pregnant, breastfeeding, or of childbearing potential,
9. Surgery including left ventricular assist device implantation or cardiac transplantation,
10. Previously enrolled in this trial,
11. Follow-up not possible,
12. History of moderate or severe mitral valvular lesion (stenosis or regurgitation) that is not corrected during index cardiac surgery.
Study Location
University of Alberta Hospital
University of Alberta HospitalEdmonton, Alberta
Canada
Contact Study Team
Steven Meyer, MD
Toronto General Hospital
Toronto General HospitalToronto, Ontario
Canada
Contact Study Team
Vivek Rao, MD
Sunnybrook Hospital
Sunnybrook HospitalToronto, Ontario
Canada
Contact Study Team
Stephen Fremes, MD
Hamilton General Hospital
Hamilton General HospitalHamilton, Ontario
Canada
Contact Study Team
IUCPQ-ULaval
IUCPQ-ULavalQuebec City, Quebec
Canada
Contact Study Team
Eric Dumont, MD
St. Boniface Hospital
St. Boniface HospitalWinnipeg, Manitoba
Canada
Contact Study Team
Michael Yamashita, MD
Montreal Heart Institute
Montreal Heart InstituteMontréal, Quebec
Canada
Contact Study Team
Philippe Demers, MD
- Study Sponsored By
- Population Health Research Institute
- Participants Required
- More Information
- Study ID:
NCT04284839