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

NCT04284839 | Recruiting Phase 3 DMC

• 1 other identifier: DANCE-2020
• Study Type: interventional
• Target: 3,500
• Locations: 3 countries
• Sites: 19

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 surgery in patients with atrial fibrillation requiring oral anticoagulation.

Conditions

Bleeding Post Cardiac Surgery; Indication for Anticoagulation

Keywords

Direct Oral Anticoagulant; Vitamin K Antagonist; Bleeding

Outcome Measures

Primary Outcomes (1)

• Major Bleeding

  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)

  30-Days post-randomization

Secondary Outcomes (9)

• Composite of stroke and non-central nervous system systemic arterial embolism at 30 and 90 days.

  30-Days and 90-Days post-randomization

• Major Bleeding

  90-Days post-randomization

• Pleural or pericardial effusion requiring drainage

  30-Days and 90-Days post-randomization

• Systemic arterial embolism

  30-Days and 90-Days post-randomization

• Ischemic stroke

  30-Days and 90-Days post-randomization

Other Outcomes (13)

• Minor Bleeding

  30-Days and 90-Days post-randomization

• All bleeding (major plus minor)

  30-Days and 90-Days post-randomization

• Myocardial Infarction

  30-Days and 90-Days post-randomization

Study Arms (2)

Direct Oral Anticoagulation (DOAC)

ACTIVE COMPARATOR

Patients in the intervention group 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.

Drug: DOAC

Vitamin K Antagonist

PLACEBO COMPARATOR

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

Drug: VKA

Interventions

DOAC DRUG

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.

Also known as: Apixaban, Dabigatran, Edoxaban, Rivaroxaban

Direct Oral Anticoagulation (DOAC)

VKA DRUG

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

Also known as: Warfarin

Vitamin K Antagonist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Population Health Research Institute: lead
• Hamilton Health Sciences Corporation: collaborator

Study Sites (19)

St Vincent's Hospital Melbourne

Fitzroy, Victoria, 3065, Australia

RECRUITING

Royal Melbourne Hospital, University of Melbourne

Parkville, Victoria, 3050, Australia

NOT YET RECRUITING

University of Alberta Hospital

Edmonton, Alberta, T6G 2C8, Canada

RECRUITING

University of British Columbia

Vancouver, British Columbia, V6T 1Z3, Canada

RECRUITING

St. Boniface Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

RECRUITING

Saint John Regional Hospital

Saint John, New Brunswick, E2L4L2, Canada

ACTIVE NOT RECRUITING

Health Science Centre

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

RECRUITING

Health Sciences North Research Institute

Greater Sudbury, Ontario, P3E 5J1, Canada

RECRUITING

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

RECRUITING

Sunnybrook Hospital

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

RECRUITING

Hôpital Sacré-Coeur de Montréal

Montreal, Quebec, H4J1C5, Canada

ACTIVE NOT RECRUITING

IUCPQ-ULaval

Québec, Quebec, G1V 4G5, Canada

RECRUITING

Heart Center Leipzig

Leipzig, Saxony, 04289, Germany

ACTIVE NOT RECRUITING

University Hospital Jena

Jena, Thuringia, Germany, Germany

RECRUITING

University Hospital Bonn Heart Center

Bonn, 53127, Germany

ACTIVE NOT RECRUITING

West-German Heart and Vascular Center, University of Duisburg-Essen

Essen, 45147, Germany

NOT YET RECRUITING

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

RECRUITING

MeSH Terms

Conditions

Hemorrhage

Interventions

apixaban; Dabigatran; edoxaban; Rivaroxaban; Warfarin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans

Study Officials

• Emilie Belley-Cote, MD, MSc

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilie Belley-Cote, MD, MSc

CONTACT

905-527-4322; emilie.belley-cote@phri.ca

Richard Whitlock, MD, PhD

CONTACT

905-527-4322; richard.whitlock@phri.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: February 26, 2020
• Study Start: July 18, 2021
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5); CA (12); AU (2)