Apixaban VS Warfarin in AF Pts First Three Months After Repair or BIO AVR MVR

Starting soon · Phase 3

Conditions studied: Valve Disease, Heart, Atrial Fibrillation (AF), Valve Replacement Surgery, Aortic Valve Surgery, Mitral Valve Annuloplasty, Mitral Valve Repair, Mitral Valve Surgery

In brief

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.

Key facts

Study ID: NCT07434661
Run by: Meshalkin Research Institute of Pathology of Circulation
People needed: 120
Starts: 2026-02-01
Expected to finish: 2029-01-01
Last updated by the study team: 2026-02-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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)
Left ventricular thrombus
Ongoing bleeding, hemorrhagic disorders, or bleeding diathesis
Known contraindication for any DOAC or VKA
Women who are pregnant, breastfeeding, or of childbearing potential
Follow-up not possible

Where it is running

"E.Meshalkin National Medical Research Center" of the Ministry of Health of the Russian Federation — Novosibirsk, Russia

Full record on ClinicalTrials.gov

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