RecruitingPhase 3NCT04284839

The Direct Oral Anticoagulation Versus Vitamin K Antagonist After Cardiac Surgery Trial


Sponsor

Population Health Research Institute

Enrollment

3,500 participants

Start Date

Jul 18, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study, called the Direct Oral Anticoagulation Versus Vitamin K Antagonist After Cardiac Surgery Trial (DOAC-CS), is comparing two types of blood thinners — direct oral anticoagulants (DOACs, such as rivaroxaban or apixaban) versus traditional vitamin K antagonists (like warfarin) — in patients who develop atrial fibrillation (an irregular heartbeat) around the time of open heart surgery. Both types of drugs prevent dangerous blood clots, but DOACs may be easier to manage and have fewer complications. You may be eligible if: - You are at least 18 years old - You had open heart surgery within the last 10 days - You have atrial fibrillation (either pre-existing or new after surgery) that requires blood thinning medication - You or your substitute decision-maker has given informed consent You may NOT be eligible if: - You received a mechanical valve replacement - You have antiphospholipid syndrome (triple positive) - You have severe kidney failure (creatinine clearance below 15 ml/min) - You have significant liver disease (Child-Pugh B or C) - You have a blood clot in your left heart ventricle - You have active bleeding or a bleeding disorder - You have a known contraindication to any DOAC or vitamin K antagonist - You are a woman who is pregnant, breastfeeding, or of childbearing potential - You had a left ventricular assist device or heart transplant - You have moderate to severe mitral valve disease that was not corrected during your surgery Talk to your cardiac surgeon or cardiologist if you are recovering from heart surgery and have atrial fibrillation.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDOAC

Patients will receive a DOAC at doses recommended for the indication, adjusted for their renal function is required. The choice of DOAC will be at the discretion of the treating physician.

DRUGVKA

Patients in the control group will receive VKA once daily; the individual dose will be titrated to achieve a guideline-recommended INR range.


Locations(19)

St Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia

Royal Melbourne Hospital, University of Melbourne

Parkville, Victoria, Australia

University of Alberta Hospital

Edmonton, Alberta, Canada

University of British Columbia

Vancouver, British Columbia, Canada

St. Boniface Hospital

Winnipeg, Manitoba, Canada

Saint John Regional Hospital

Saint John, New Brunswick, Canada

Health Science Centre

St. John's, Newfoundland and Labrador, Canada

Health Sciences North Research Institute

Greater Sudbury, Ontario, Canada

Hamilton General Hospital

Hamilton, Ontario, Canada

Sunnybrook Hospital

Toronto, Ontario, Canada

Toronto General Hospital

Toronto, Ontario, Canada

Montreal Heart Institute

Montreal, Quebec, Canada

Hôpital Sacré-Coeur de Montréal

Montreal, Quebec, Canada

IUCPQ-ULaval

Québec, Quebec, Canada

Heart Center Leipzig

Leipzig, Saxony, Germany

University Hospital Jena

Jena, Thuringia, Germany

University Hospital Bonn Heart Center

Bonn, Germany

West-German Heart and Vascular Center, University of Duisburg-Essen

Essen, Germany

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

View Full Details on ClinicalTrials.gov

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NCT04284839