The Direct Oral Anticoagulation Versus Vitamin K Antagonist After Cardiac Surgery Trial
Bleeding Post Cardiac Surgery | Indication for AnticoagulationThe 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.
null
Conditions de participation
-
Sexe:
ALL -
Âges admissibles:
18 and up
Critères de participation
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 \<15 ml/min),
4. Known significant liver disease (Child-Pugh classification B and C),
5. Left ventricular thrombus,
6. Ongoing bleeding, hemorrhagic disorders, or bleeding diathesis,
7. Known contraindication for any DOAC or VKA,
8. Women who are pregnant, breastfeeding, or of childbearing potential,
9. Surgery including left ventricular assist device implantation or cardiac transplantation,
10. Previously enrolled in this trial,
11. Follow-up not possible,
12. History of moderate or severe mitral valvular lesion (stenosis or regurgitation) that is not corrected during index cardiac surgery.
Lieu de l'étude
University of Alberta Hospital
University of Alberta HospitalEdmonton, Alberta
Canada
Contactez l'équipe d'étude
Steven Meyer, MD
Toronto General Hospital
Toronto General HospitalToronto, Ontario
Canada
Contactez l'équipe d'étude
Vivek Rao, MD
Sunnybrook Hospital
Sunnybrook HospitalToronto, Ontario
Canada
Contactez l'équipe d'étude
Stephen Fremes, MD
Hamilton General Hospital
Hamilton General HospitalHamilton, Ontario
Canada
Contactez l'équipe d'étude
IUCPQ-ULaval
IUCPQ-ULavalQuebec City, Quebec
Canada
Contactez l'équipe d'étude
Eric Dumont, MD
St. Boniface Hospital
St. Boniface HospitalWinnipeg, Manitoba
Canada
Contactez l'équipe d'étude
Michael Yamashita, MD
Montreal Heart Institute
Montreal Heart InstituteMontréal, Quebec
Canada
Contactez l'équipe d'étude
Philippe Demers, MD
- Étude parrainée par
- Population Health Research Institute
- Participants recherchés
- Plus d'informations
- ID de l'étude:
NCT04284839