Status:
RECRUITING
The Direct Oral Anticoagulation Versus Vitamin K Antagonist After Cardiac Surgery Trial
Lead Sponsor:
Population Health Research Institute
Collaborating Sponsors:
Hamilton Health Sciences Corporation
Conditions:
Bleeding Post Cardiac Surgery
Indication for Anticoagulation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
Approximately 36,000 Canadian adults undergo cardiac surgery annually. Of these patients, about 10% have a prior history of atrial fibrillation (AF). In the early post-operative period after cardiac s...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
3500 Patients enrolled
Trial Details
Trial ID
NCT04284839
Start Date
July 18 2021
End Date
June 1 2027
Last Update
September 29 2025
Active Locations (19)
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1
St Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia, 3065
2
Royal Melbourne Hospital, University of Melbourne
Parkville, Victoria, Australia, 3050
3
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2C8
4
University of British Columbia
Vancouver, British Columbia, Canada, V6T 1Z3