Recruiting
Phase 3

Direct Oral Anticoagulation & Vitamin K Antagonist

Sponsor:

Population Health Research Institute

Code:

NCT04284839

Conditions

Bleeding Post Cardiac Surgery

Indication for Anticoagulation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

DOAC

VKA

Study Details

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

Study ID

NCT04284839

Start date

Jul 18, 2021

Status verified date

Sep, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

3500 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Direct Oral Anticoagulation (DOAC)

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.

placebo comparator: Vitamin K Antagonist

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

Interventions

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.

Primary outcome measure

  • Major Bleeding [ Time Frame: 30-Days post-randomization ]

Central Contacts and Locations

Central contacts

Emilie Belley-Cote, MD, MSc

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

Richard Whitlock, MD, PhD

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

Locations

University of Alberta Hospital

Recruiting

Edmonton, Alberta, Canada, T6G 2C8

Principal Investigator:

Steven Meyer, MD

University of British Columbia

Recruiting

Vancouver, British Columbia, Canada, V6T 1Z3

Principal Investigator:

Erica Wang, PharmD

St. Boniface Hospital

Recruiting

Winnipeg, Manitoba, Canada, R2H 2A6

Principal Investigator:

Michael Yamashita, MD

Health Science Centre

Recruiting

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

Principal Investigator:

Hasib Hanif, MD

Health Sciences North Research Institute

Recruiting

Greater Sudbury, Ontario, Canada, P3E 5J1

Principal Investigator:

Bindu Bittira, MD

Hamilton General Hospital

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

Contacts

Emilie Belley-Cote, MD, MSc

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

Sunnybrook Hospital

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Principal Investigator:

Stephen Fremes, MD

Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Principal Investigator:

Vivek Rao, MD

Montreal Heart Institute

Recruiting

Montreal, Quebec, Canada, H1T 1C8

Principal Investigator:

Philippe Demers, MD

IUCPQ-ULaval

Recruiting

Québec, Quebec, Canada, G1V 4G5

Principal Investigator:

Eric Dumont, MD

More Information

Sponsor

Population Health Research Institute

Last update posted

Sep 29, 2025

Last verified

Sep, 2025

Keywords

  • Direct Oral Anticoagulant
  • Vitamin K Antagonist
  • Bleeding

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Population Health Research Institute on 2025-09-29.