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Recruiting
NCT04284839
The Direct Oral Anticoagulation Versus Vitamin K Antagonist After Cardiac Surgery Trial
Conditions: Bleeding Post Cardiac Surgery, Indication for Anticoagulation
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 3500
Sponsor: Population Health Research Institute
Location: St Vincent's Hospital Melbourne Fitzroy Victoria
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 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.
Exclusion Criteria:
1. Mechanical valve replacement,
2. Antiphospholipid syndrome (triple positive),
3. Severe renal failure (Cockcroft-Gault equation; creatinine clearance \
Source: ClinicalTrials.gov (NCT04284839). StuddyBuddy aggregates publicly available trial information.
