Apixaban VS Warfarin in AF Pts First Three Months After Repair or BIO AVR MVR (NCT07434661) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Apixaban VS Warfarin in AF Pts First Three Months After Repair or BIO AVR MVR
Russia120 participantsStarted 2026-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Major Bleeding
Timeframe: 3 months
2
Death and/or thromboembolic complications
Timeframe: 3 months
Trial details
NCT IDNCT07434661
SponsorMeshalkin Research Institute of Pathology of Circulation