A Phase 3 interventional study of DOAC and VKA in Bleeding Post Cardiac Surgery and Indication for Anticoagulation, sponsored by Population Health Research Institute. Recruiting at 19 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Population Health Research Institute · Phase 3, Interventional, and Treatment
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.
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.
1,383 studies on the registry are indexed under Hemorrhage; 244 are open to participants now.
This study's planned enrollment of 3,500 is above the median of 102 across 926 interventional studies indexed under Hemorrhage.
Browse Hemorrhage studies →Population Health Research Institute is the lead sponsor of 115 studies on the registry; 26 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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)
Time frame: 30-Days post-randomization
Composite of stroke and non-central nervous system systemic arterial embolism at 30 and 90 days.
Time frame: 30-Days and 90-Days post-randomization
Major Bleeding
Time frame: 90-Days post-randomization
Pleural or pericardial effusion requiring drainage
Time frame: 30-Days and 90-Days post-randomization
Systemic arterial embolism
Time frame: 30-Days and 90-Days post-randomization
Ischemic stroke
Time frame: 30-Days and 90-Days post-randomization
Deep vein thrombosis
Time frame: 30-Days and 90-Days post-randomization
Pulmonary Embolism
Time frame: 30-Days and 90-Days post-randomization
Length of post-operative hospital stay
Time frame: 30-Days and 90-Days post-randomization
All-Cause Mortality
Time frame: 6 Months post-randomization
Minor Bleeding
Tertiary outcome
Time frame: 30-Days and 90-Days post-randomization
All bleeding (major plus minor)
Tertiary outcome
Time frame: 30-Days and 90-Days post-randomization
Myocardial Infarction
Time frame: 30-Days and 90-Days post-randomization
Valve Thrombosis
Tertiary outcome
Time frame: 30-Days and 90-Days post-randomization
Hemorrhagic stroke
Tertiary outcome
Time frame: 30-Days and 90-Days post-randomization
All Stroke
Tertiary outcome
Time frame: 30-Days and 90-Days post-randomization
All Arterial Thrombosis/thromboembolism
Tertiary outcome: ischemic stroke, systemic arterial embolism, myocardial infarction, valve thrombosis
Time frame: 30-Days and 90-Days post-randomization
Quality of Life - EQ-5D-5L
Tertiary outcome: Measured by The EQ-5D-5L Questionnaire
Time frame: 30-Days and 90-Days post-randomization
Patient Satisfaction with Anticoagulant treatment
Tertiary outcome: Assessed by the Perception of Anticoagulant Treatment Questionnaire
Time frame: 30-Days and 90-Days post-randomization
Subclinical Valve Thrombosis on CT scan
Substudy outcome
Time frame: 60 to 90-Days post-randomization
Mean Aortic Valve g=Gradient on echocardiogram
Substudy outcome
Time frame: 60 to 90-Days post-randomization
Aortic Valve Reintervention
Substudy outcome
Time frame: 60 to 90-Days post-randomization
Association between subclinical valve thrombosis and clinically significant aortic valve thrombosis, stroke or systemic embolism
Time frame: 90 days
Not enrolling at this site.
Not enrolling at this site.
Not enrolling at this site.
Plan to share: No — We will establish a plan for the full-scale study but there is no plan to make IPD available to other researchers.
Started Jul 2021 (actual). Primary completion is estimated for Jun 2027, 71 months after the start.
Of 45 non-industry phase 3 interventional studies under Hemorrhage, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 72. This study's planned 71 months is above that.
Counting every sponsor, half of 71 studies reached it within 42 months; a quarter within 26 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Apixaban
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