The Direct Oral Anticoagulation Versus Vitamin K Antagonist After Cardiac Surgery Trial

Recruiting now · Phase 3

Conditions studied: Bleeding Post Cardiac Surgery, Indication for Anticoagulation

In brief

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.

Key facts

Study ID

NCT04284839

Run by

Population Health Research Institute

People needed

3500

Starts

2021-07-18

Expected to finish

2027-06-01

Last updated by the study team

2025-09-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 may not qualify 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,
• 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.

Where it is running

• University Medical Center Hamburg-Eppendorf — Hamburg, Germany (enrolling)
• Sunnybrook Hospital — Toronto, Ontario, Canada (enrolling)
• Toronto General Hospital — Toronto, Ontario, Canada (enrolling)
• Montreal Heart Institute — Montreal, Quebec, Canada (enrolling)
• IUCPQ-ULaval — Québec, Quebec, Canada (enrolling)
• University Hospital Jena — Jena, Thuringia, Germany (enrolling)
• St Vincent's Hospital Melbourne — Fitzroy, Victoria, Australia (enrolling)
• University of Alberta Hospital — Edmonton, Alberta, Canada (enrolling)
• University of British Columbia — Vancouver, British Columbia, Canada (enrolling)
• St. Boniface Hospital — Winnipeg, Manitoba, Canada (enrolling)
• Health Science Centre — St. John's, Newfoundland and Labrador, Canada (enrolling)
• Health Sciences North Research Institute — Greater Sudbury, Ontario, Canada (enrolling)
• Hamilton General Hospital — Hamilton, Ontario, Canada (enrolling)
• Royal Melbourne Hospital, University of Melbourne — Parkville, Victoria, Australia
• West-German Heart and Vascular Center, University of Duisburg-Essen — Essen, Germany
• Hôpital Sacré-Coeur de Montréal — Montreal, Quebec, Canada
• University Hospital Bonn Heart Center — Bonn, Germany
• Saint John Regional Hospital — Saint John, New Brunswick, Canada
• Heart Center Leipzig — Leipzig, Saxony, Germany

Full record on ClinicalTrials.gov

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