NCT07434661

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

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Meshalkin Research Institute of Pathology of Circulation · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Oral anticoagulation with vitamin K antagonists (VKAs) is currently recommended for 3 months following surgical reconstruction or bioprosthetic replacement of the mitral and aortic valves, regardless of rhythm status. Despite their effectiveness, the use of warfarin is limited by its narrow therapeutic index, which requires frequent international normalized ratio (INR) measurements to ensure adequate anticoagulation levels. This key limitation leads to failure to maintain target INR levels and treatment discontinuation. Additionally, in the first 3 months after heart surgery, the duration of the therapeutic period is short, even with careful monitoring by experienced physicians. Over the past decade, direct oral anticoagulants (DOACs)-factor Xa or thrombin inhibitors-have gained widespread use in anticoagulant therapy. It has been demonstrated that DOAC treatment in patients with atrial fibrillation reduces the risk of stroke or systemic embolism and carries a similar risk of major bleeding compared to VKAs during long-term follow-up in patients with atrial fibrillation. Moreover, they offer rapid onset of action, fixed dosing, no need for laboratory monitoring, and minimal interactions with food and other medications. In the postoperative period, DOAC use may also shorten hospital stays and reduce costs. However, the safety of DOACs in the first months after surgical valve correction (reconstruction/bioprosthetic replacement of the mitral and aortic valves) remains uncertain, which is reflected in the recommendation classes for anticoagulant therapy following these procedures. The purpose of this study is to establish whether Apixaban is as safe and effective as Warfarin in the first 3 months after reconstruction or bioprosthetics of the mitral and aortic valvescardiac surgery in patients with atrial fibrillation requiring oral anticoagulation.

Conditions

• Valve Disease, Heart
• Atrial Fibrillation (AF)
• Valve Replacement Surgery
• Aortic Valve Surgery
• Mitral Valve Annuloplasty
• Mitral Valve Repair
• Mitral Valve Surgery

Interventions

Type	Name	Description
DRUG	Apixaban	Patients in the intervention group will receive Apixaban at doses recommended for the indication, adjusted for their renal function is required.
DRUG	Warfarin	Patients in the control group will receive VKA once daily; the individual dose will be titrated to achieve a guideline-recommended INR range.

Timeline

• Start date: 2026-02-01
• Primary completion: 2028-01-01
• Completion: 2029-01-01
• First posted: 2026-02-25
• Last updated: 2026-02-25

Locations

1 site across 1 country: Russia