NCT07434661Not yet recruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 25 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 21 Jan 2026
- Start date
- Feb 2026
- Primary completion date
- Jan 2028
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Diseases
- Atrial fibrillation
- NCT number
- NCT07434661
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 120
- From Feb 2026 to the primary completion date, Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Antiphospholipid syndrome (triple positive)
- Known significant liver disease (Child-Pugh classification B and C)
- Ongoing bleeding, hemorrhagic disorders, or bleeding diathesis
Lab values
- Severe renal failure (Cockcroft-Gault equation; creatinine clearance \<15 ml/min)
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| E.Meshalkin National medical research center of the Ministry of Health of the Russian Federation Coordinator of this site? Confirm its status | Novosibirsk | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.