NCT04284839RecruitingPhase 3
The Direct Oral Anticoagulation versus Vitamin K Antagonist after Cardiac Surgery (DANCE) Trial
Source: EU CTIS (euclinicaltrials.eu) · Last updated 10 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1000 (estimated)
- First submitted
- 1 Aug 2023
- Start date
- 25 Oct 2024
- Lead sponsor
- Hamilton Health Sciences Corporation
- Diseases
- Atrial fibrillation
- NCT number
- NCT04284839
- EU CT number
- 2023-504504-28-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1000
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously enrolled in this trial
Other illness
- History of moderate or severe rheumatic valvular lesion (stenosis or regurgitation) that is not corrected during index cardiac surgery
- Antiphospholipid syndrome (triple positive)
- Known significant liver disease (Child-Pugh classification B and C)
- Ongoing bleeding, hemorrhagic disorders, or bleeding diathesis
- Surgery including left ventricular assist device implantation or cardiac transplantation
Lab values
- Severe renal failure (Cockcroft-Gault equation; creatinine clearance <15 ml/min)
Other
- Mechanical valve replacement
- Follow-up not possible
- Left ventricular thrombus
- Known contraindication for any direct oral anticoagulant or vitamin K antagonist
- Women who are pregnant, breastfeeding, or of childbearing potential
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitaetsklinikum Bonn AöR Coordinator of this site? Confirm its status | Bonn | Germany | Recruiting |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Recruiting |
| UNIVERSITÄTSKLINIKUM FREIBURG Coordinator of this site? Confirm its status | Freiburg | Germany | Recruiting |
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| University Hospital Jena KöR Coordinator of this site? Confirm its status | Jena | Germany | Recruiting |
| Herzzentrum Leipzig GmbH Coordinator of this site? Confirm its status | Leipzig | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.