SAFE-HEART is a single-centre, randomized controlled trial comparing the safety and efficiency of Apixaban versus Warfarin in the early period (3 months) after repair or bioprosthetics of the mitral and aortic valve cardiac surgery in patients with atrial fibrillation requiring oral anticoagulation.
Age ≥18 years at the time of enrolment
Open heart aortic or mitral valve repair or biological valve replacement 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
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)
Meshalkin Research Institute of Pathology of Circulation
Lead sponsor