The Direct Oral Anticoagulation Versus Vitamin K Antagonist After Cardiac Surgery Trial
Population Health Research Institute
3,500 participants
Jul 18, 2021
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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.
Exclusion Criteria12
- 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,
- 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.
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Interventions
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.
Patients in the control group will receive VKA once daily; the individual dose will be titrated to achieve a guideline-recommended INR range.
Locations(19)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04284839