The Direct Oral Anticoagulation Versus Vitamin K Antagonist After Cardiac Surgery Trial
Recruiting
Phase 3
Interventional Study
Bleeding Post Cardiac Surgery
Indication for Anticoagulation
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 3,500 (estimated)
- Sponsor
- Population Health Research Institute · Other
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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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age ≥18 years at the time of enrolment,
2. Open heart surgery in the last 10 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.
Exc…
Contacts