The Direct Oral Anticoagulation versus Vitamin K Antagonist after Cardiac Surgery (DANCE) Trial
- Conditions
- Patients with atrial fibrillation requiring anticoagulation.MedDRA version: 20.0Level: PTClassification code: 10003658Term: Atrial fibrillation Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- CTIS2023-504504-28-00
- Lead Sponsor
- Hamilton Health Sciences Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 6215
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method