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The Direct Oral Anticoagulation versus Vitamin K Antagonist after Cardiac Surgery (DANCE) Trial
EU CTIS ID: 2023-504504-28-00
What this study is testing
The objective in the vanguard phase of the DANCE trial is to assess the feasibility of conducting a large randomized controlled trial (RCT) evaluating the safety of DOAC versus VKA after cardiac surgery in patients with AF requiring oral anticoagulation. The objectives in the full trial are to evaluate the safety of DOAC versus VKA after cardiac surgery in patients with AF requiring anticoagulation.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Mechanical valve replacement
- Previously enrolled in this trial
- Follow-up not possible
- History of moderate or severe rheumatic valvular lesion (stenosis or regurgitation) that is not corrected during index cardiac surgery
- Antiphospholipid syndrome (triple positive)
- Severe renal failure (Cockcroft-Gault equation; creatinine clearance <15 ml/min)
See the full eligibility criteria
- 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.
- Mechanical valve replacement
- Previously enrolled in this trial
- Follow-up not possible
- History of moderate or severe rheumatic valvular lesion (stenosis or regurgitation) that is not corrected during index cardiac surgery
- 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 direct oral anticoagulant or vitamin K antagonist
- Women who are pregnant, breastfeeding, or of childbearing potential
- Surgery including left ventricular assist device implantation or cardiac transplantation
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Russian Federation
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Russian Federation. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.