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

NCT04284839 · tracked via the Priya Life Science Australia tracker

Sponsor

Population Health Research Institute

Phase

Phase 3

Started

2021-07-18

Last updated

2026-09-18

Condition(s) studied

Bleeding Post Cardiac SurgeryIndication for Anticoagulation

Investigational drug(s) / intervention(s)

DOAC →VKA →

DOAC: Patients will receive a DOAC at doses recommended for the indication, adjusted for their renal function is required. The choice of DOAC will be at the discretion of the treating physician.

VKA: Patients in the control group will receive VKA once daily; the individual dose will be titrated to achieve a guideline-recommended INR range.

Study 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 surgery in patients with atrial fibrillation requiring oral anticoagulation.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Major Bleeding — 30-Days post-randomization
Major bleeding at 30 days, defined as bleeding that results in death and/or symptomatic bleeding in a critical area or organ, bleeding into a surgical site requiring reoperation, bleeding leading to hospitalization (including presentation to an acute care facility without overnight stay) and/or bleeding that causes a drop in the hemoglobin level of 20g/L or more or that which requires the transfusion of ≥2 units of packed red blood cells or whole blood (as defined by the International Society of Thrombosis and Hemostasis)

Trial sites (19)

Facility	City	Region	Status
St Vincent's Hospital Melbourne	Fitzroy	Victoria	Recruiting
Royal Melbourne Hospital, University of Melbourne	Parkville	Victoria	Not Yet Recruiting
University of Alberta Hospital	Edmonton	Alberta	Recruiting
University of British Columbia	Vancouver	British Columbia	Recruiting
St. Boniface Hospital	Winnipeg	Manitoba	Recruiting
Saint John Regional Hospital	Saint John	New Brunswick	Active Not Recruiting
Health Science Centre	St. John's	Newfoundland and Labrador	Recruiting
Health Sciences North Research Institute	Greater Sudbury	Ontario	Recruiting
Hamilton General Hospital	Hamilton	Ontario	Recruiting
Sunnybrook Hospital	Toronto	Ontario	Recruiting
Toronto General Hospital	Toronto	Ontario	Recruiting
Montreal Heart Institute	Montreal	Quebec	Recruiting
Hôpital Sacré-Coeur de Montréal	Montreal	Quebec	Recruiting
IUCPQ-ULaval	Québec	Quebec	Recruiting
Heart Center Leipzig	Leipzig	Saxony	Active Not Recruiting
University Hospital Jena	Jena	Thuringia	Recruiting
University Hospital Bonn Heart Center	Bonn	Germany	Active Not Recruiting
West-German Heart and Vascular Center, University of Duisburg-Essen	Essen	Germany	Not Yet Recruiting
University Medical Center Hamburg-Eppendorf	Hamburg	Germany	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04284839 on ClinicalTrials.gov ↗ ← All trials in Australia