Apixaban compared with warfarin for atrial fibrillation after heart valve surgery
Compares apixaban and warfarin in adults with atrial fibrillation after valve surgery.
Plain-language title generated from the registry record
Registry title: Apixaban VS Warfarin in AF Pts First Three Months After Repair or BIO AVR MVR
Key facts
- Where
- Novosibirsk, RussiaSee the site
- Phase
- Phase 3
Where in Russia
- E.Meshalkin National medical research center of the Ministry of Health of the Russian FederationNovosibirsk, RussiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Meshalkin Research Institute of Pathology of Circulation
- Trial code
- NCT07434661
- Record updated
- 25 February 2026
- Original description
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.Read full original descriptionShow less
Safety and Efficacy of Apixaban Compared With Warfarin in Patients With Atrial Fibrillation in the First Three Months After Mitral or Aortic Biological Valve Replacement or Repair
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.
Inclusion: 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.
Exclusion: Antiphospholipid syndrome (triple positive); Known significant liver disease (Child-Pugh classification B and C); Ongoing bleeding, hemorrhagic disorders, or bleeding diathesis; Severe renal failure (Cockcroft-Gault equation; creatinine clearance <15 ml/min); Mechanical valve replacement; Left ventricular thrombus; Known contraindication for any DOAC or VKA; Women who are pregnant, breastfeeding, or of childbearing potential; Follow-up not possible.