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Apixaban VS Warfarin in AF Pts First Three Months After Repair or BIO AVR MVR
Sponsor: Meshalkin Research Institute of Pathology of Circulation
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2026-02
Completion Date
2029-01
Last Updated
2026-02-25
Healthy Volunteers
No
Conditions
Interventions
Apixaban
Patients in the intervention group will receive Apixaban at doses recommended for the indication, adjusted for their renal function is required.
Warfarin
Patients in the control group will receive VKA once daily; the individual dose will be titrated to achieve a guideline-recommended INR range.
Locations (1)
"E.Meshalkin National Medical Research Center" of the Ministry of Health of the Russian Federation
Novosibirsk, Russia