The Direct Oral Anticoagulation Versus Vitamin K Antagonist After Cardiac Surgery Trial
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPopulation Health Research Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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),
Trial design
Design model
Factorial
Treatments tested in this trial
DOAC
DrugPatients 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
DrugPatients in the control group will receive VKA once daily; the individual dose will be titrated to achieve a guideline-recommended INR range.
Treatment groups
3,500 Participants
are divided into 2 treatment groupsGroup A: Direct Oral Anticoagulation (DOAC)Active comparator 1 intervention
Group B: Vitamin K AntagonistPlacebo comparator 1 intervention
Trial outcomes
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)
Time frame
30-Days post-randomizationSecondary outcomes
1
Composite of stroke and non-central nervous system systemic arterial embolism at 30 and 90 days.
Time frame
30-Days and 90-Days post-randomization2
Major Bleeding
Time frame
90-Days post-randomization3
Pleural or pericardial effusion requiring drainage
Time frame
30-Days and 90-Days post-randomization4
Systemic arterial embolism
Time frame
30-Days and 90-Days post-randomizationOther outcomes
1
Minor Bleeding
Tertiary outcome
Time frame
30-Days and 90-Days post-randomization2
All bleeding (major plus minor)
Tertiary outcome
Time frame
30-Days and 90-Days post-randomization3
Myocardial Infarction
Time frame
30-Days and 90-Days post-randomization4
Valve Thrombosis
Tertiary outcome
Time frame
30-Days and 90-Days post-randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Population Health Research Institute
Lead sponsor
Hamilton Health Sciences Corporation
Collaborator
Source ClinicalTrials.gov