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

RecruitingPhase 3Ages 18 Years - anyAllPopulation Health Research Institute
NCT04284839 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • DOAC
  • VKA
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Where

19 sites
St Vincent's Hospital Melbourne
Fitzroy, Australia
Royal Melbourne Hospital, University of Melbourne
Parkville, Australia
University of Alberta Hospital
Edmonton, Canada
University of British Columbia
Vancouver, Canada
St. Boniface Hospital
Winnipeg, Canada
Saint John Regional Hospital
Saint John, Canada
Health Science Centre
St. John's, Canada
Health Sciences North Research Institute
Greater Sudbury, Canada

…and 11 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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