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

Condition(s) studied

Investigational drug(s) / intervention(s)

DOAC: 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.

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

Study 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

Primary outcome measure(s)

• Major Bleeding — 30-Days post-randomization
  Major bleeding at 30 days, defined as bleeding that results in death and/or symptomatic bleeding in a critical area or organ, bleeding into a surgical site requiring reoperation, bleeding leading to hospitalization (including presentation to an acute care facility without overnight stay) and/or bleeding that causes a drop in the hemoglobin level of 20g/L or more or that which requires the transfusion of ≥2 units of packed red blood cells or whole blood (as defined by the International Society of Thrombosis and Hemostasis)

Trial sites (19)

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