The Direct Oral Anticoagulation Versus Warfarin After Cardiac Surgery Trial

• Status: Recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

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 an indication for oral anticoagulation.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McMaster University; Population Health Research Institute
• Collaborator: Hamilton Health Sciences Corporation
• Treatments: Apixaban; Dabigatran; Edoxaban; Rivaroxaban; Vitamin K; Warfarin

Criteria

Inclusion Criteria:

1. Age ≥18 years at the time of enrolment,

2. Open heart surgery in the last 7 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:

1. Mechanical valve replacement,

2. Antiphospholipid syndrome (triple positive),

3. Severe renal failure (Cockcroft-Gault equation; creatinine clearance <30 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. Previously enrolled in this trial,

10. Follow-up not possible.