The Direct Oral Anticoagulation Versus Vitamin K Antagonist After Cardiac Surgery Trial
NCT ID: NCT04284839
Last Updated: 2025-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
3500 participants
INTERVENTIONAL
2021-07-18
2027-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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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.
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.
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.
VKA
Patients in the control group will receive VKA once daily; the individual dose will be titrated to achieve a guideline-recommended INR range.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Hamilton Health Sciences Corporation
OTHER
Population Health Research Institute
OTHER
Responsible Party
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Principal Investigators
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Emilie Belley-Cote, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Locations
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St Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
Royal Melbourne Hospital, University of Melbourne
Parkville, Victoria, Australia
University of Alberta Hospital
Edmonton, Alberta, Canada
University of British Columbia
Vancouver, British Columbia, Canada
St. Boniface Hospital
Winnipeg, Manitoba, Canada
Saint John Regional Hospital
Saint John, New Brunswick, Canada
Health Science Centre
St. John's, Newfoundland and Labrador, Canada
Health Sciences North Research Institute
Greater Sudbury, Ontario, Canada
Hamilton General Hospital
Hamilton, Ontario, Canada
Sunnybrook Hospital
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Hôpital Sacré-Coeur de Montréal
Montreal, Quebec, Canada
IUCPQ-ULaval
Québec, Quebec, Canada
Heart Center Leipzig
Leipzig, Saxony, Germany
University Hospital Jena
Jena, Thuringia, Germany
University Hospital Bonn Heart Center
Bonn, , Germany
West-German Heart and Vascular Center, University of Duisburg-Essen
Essen, , Germany
University Medical Center Hamburg-Eppendorf
Hamburg, , Germany
Countries
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Central Contacts
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Facility Contacts
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Andrew Newcomb, MD
Role: primary
Alistair Royse, MD
Role: primary
Steven Meyer, MD
Role: primary
Michael Yamashita, MD
Role: primary
Stephen Fremes, MD
Role: primary
Vivek Rao, MD
Role: primary
Philippe Demers, MD
Role: primary
Eric Dumont, MD
Role: primary
Torsten Doenst, MD, PhD
Role: primary
Matthias Thielmann, MD, PhD
Role: primary
Simon Pecha, MD
Role: primary
Other Identifiers
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DANCE-2020
Identifier Type: -
Identifier Source: org_study_id
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