Bleeding Post Cardiac SurgeryPhase 3DANCENCT04284839
The Direct Oral Anticoagulation Versus Vitamin K Antagonist After Cardiac Surgery Trial
A Phase 3 study testing DOAC and VKA in people with Bleeding Post Cardiac Surgery and Indication for Anticoagulation, run by Population Health Research Institute at 19 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bleeding Post Cardiac Surgery, Indication for Anticoagulation
- What is being tested?
- DOAC and VKA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,500 participants
- Where
- 19 sitesin 3 countries
- Study dates
- 18 Jul 2021to Jun 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
19 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
19 sites in 3 countries
Canada12 sites, 11 recruiting
- Recruiting
University of Alberta Hospital
Edmonton, Alberta, T6G 2C8
Steven Meyer, MD
Steven Meyer, MD
- Recruiting
Health Sciences North Research Institute
Greater Sudbury, Ontario, P3E 5J1
Bindu Bittira, MD
- Recruiting
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
Emilie Belley-Cote, MD, MSc, 905-527-4322 ext. 40306, emilie.belley-cote@phri.ca
- Recruiting
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Philippe Demers, MD
Philippe Demers, MD
- Recruiting
Hôpital Sacré-Coeur de Montréal
Montreal, Quebec, H4J1C5
Hugues Jeanmart, MD
Hugues Jeanmart, MD
- Recruiting
IUCPQ-ULaval
Québec, Quebec, G1V 4G5
Eric Dumont, MD
Eric Dumont, MD
- Active, not recruiting
Saint John Regional Hospital
Saint John, New Brunswick, E2L4L2
- Recruiting
Health Science Centre
St. John's, Newfoundland and Labrador, A1B 3V6
Hasib Hanif, MD
- Recruiting
Sunnybrook Hospital
Toronto, Ontario, M4N 3M5
Stephen Fremes, MD
Stephen Fremes, MD
- Recruiting
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Vivek Rao, MD
Vivek Rao, MD
- Recruiting
University of British Columbia
Vancouver, British Columbia, V6T 1Z3
Erica Wang, PharmD
- Recruiting
St. Boniface Hospital
Winnipeg, Manitoba, R2H 2A6
Michael Yamashita, MD
Michael Yamashita, MD
Germany5 sites, 3 recruiting
- Active, not recruiting
University Hospital Bonn Heart Center
Bonn, 53127
- Not yet recruiting
West-German Heart and Vascular Center, University of Duisburg-Essen
Essen, 45147
Matthias Thielmann, MD, PhD
Matthias Thielmann, MD, PhD
- Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg, 20246
Simon Pecha, MD
Simon Pecha, MD
- Recruiting
University Hospital Jena
Jena, Thuringia, Germany
Torsten Doenst, MD, PhD
Torsten Doenst, MD, PhD
- Active, not recruiting
Heart Center Leipzig
Leipzig, Saxony, 04289
Australia2 sites, 2 recruiting
- Recruiting
St Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065
Andrew Newcomb, MD
Andrew Newcomb, MD
- Not yet recruiting
Royal Melbourne Hospital, University of Melbourne
Parkville, Victoria, 3050
Alistair Royse, MD
Alistair Royse, MD
About this study
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.
Read the detailed description
Approximately 36,000 Canadian adults undergo cardiac surgery annually. Of these patients, about 10% have a prior history of atrial fibrillation (AF). In the early post-operative period after cardiac surgery, 30-60% of patients develop AF and, by the time of discharge, 32% of patients who underwent cardiac surgery have an indication for oral anticoagulation (OAC). AF is associated with a significantly higher risk of stroke, even when transient, and OAC is the standard for thromboembolic prevention in these patients. In the post-operative period, the balance of benefits and risks of OAC may differ and the safest and most effective OAC in that patient population is uncertain.
Vitamin K antagonists (VKAs), such as warfarin or coumadin, are the most used anticoagulants after cardiac surgery. In the Left Atrial Appendage Occlusion Study (LAAOS) III that recruited 4811 patients from 105 centres in 27 countries, 77% of patients with AF on OAC were discharged on a VKA after cardiac surgery. Among patients taking a DOAC preoperatively, 55% were switched to a VKA after surgery. Over the first post-operative year, most of those patients were gradually transitioned back to a DOAC. Although effective, the use of VKAs is limited by a narrow therapeutic index requiring frequent international normalized ratio (INR) measurements to ensure appropriate levels of anticoagulation. This key limitation leads to non-compliance and discontinuation. In addition, in the first 3 months after cardiac surgery, time in the therapeutic range is low, even with close monitoring by experienced prescribers.
In the last decade, DOACs - inhibitors of factor Xa or thrombin- have become broadly used in patients with AF. Treatment with a DOAC in patients with AF has been demonstrated to yield a lower risk of stroke or systemic embolism and a similar risk of major bleeding when compared to VKAs during long-term follow-up. Moreover, DOACs are more convenient for both patients and clinicians. They have a rapid onset of effect, fixed dosage that obviates the need for regular monitoring, and few interactions with food and other medications. In the postoperative setting, DOACs may also lead to shorter length of stay and reduced costs.
The purpose of this study is to establish whether DOACs are as safe as VKAs in the first few weeks after heart surgery. The results of this study will impact the treatment of hundreds of thousands of patients in the world every year.
A subset of 910 DANCE participants with a recent bioprosthetic aortic and/or mitral valve replacement will be enrolled in the SUNDANCE substudy (Subclinical valve thrombosis in patients with surgical bioprosthetic valve replacement: An imaging substudy of the DANCE trial). SUNDANCE will examine the effects of DOACs versus VKAs on subclinical valve thrombosis and bioprosthetic valve function by conducting computed tomography (CT) scans and echocardiograms at 60 to 90 days after randomization.
- Being tested
- DOAC, VKA
- Keywords
- Direct Oral Anticoagulant, Vitamin K Antagonist, Bleeding
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DOACDrug
Also called Apixaban, Dabigatran, Edoxaban, Rivaroxaban
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.
VKADrug
Also called Warfarin
Patients in the control group will receive VKA once daily; the individual dose will be titrated to achieve a guideline-recommended INR range.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: VKA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 30-Days post-randomization
Secondary outcomes (9)
Composite of stroke and non-central nervous system systemic arterial embolism at 30 and 90 days.
Measured: 30-Days and 90-Days post-randomization
Major Bleeding
Measured: 90-Days post-randomization
Pleural or pericardial effusion requiring drainage
Measured: 30-Days and 90-Days post-randomization
Systemic arterial embolism
Measured: 30-Days and 90-Days post-randomization
Ischemic stroke
Measured: 30-Days and 90-Days post-randomization
Deep vein thrombosis
Measured: 30-Days and 90-Days post-randomization
Pulmonary Embolism
Measured: 30-Days and 90-Days post-randomization
Length of post-operative hospital stay
Measured: 30-Days and 90-Days post-randomization
All-Cause Mortality
Measured: 6 Months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start18 Jul 2021
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bleeding Post Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation
- Responsible party
- Sponsor
- Investigators
- Emilie Belley-Cote, MD, MSc, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04284839
- Sponsor's protocol ID
- DANCE-2020
- Acronym
- DANCE
- Status last verified
- Sep 2025
- First submitted
- 24 Feb 2020
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will establish a plan for the full-scale study but there is no plan to make IPD available to other researchers.
Publications
Eikelboom R, Whitlock RP, Sibilio S, Nguyen F, Perez R, Weitz JI, Belley-Cote E. Direct Oral Anticoagulation Versus Warfarin in Patients with Atrial Fibrillation and Bioprosthetic Heart Valves: a Retrospective, Real-World Cohort Study. Cardiovasc Drugs Ther. 2024 Feb;38(1):109-117. doi: 10.1007/s10557-022-07381-5. Epub 2022 Sep 19.
PubMed 36121587