NCT07434661

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
32mo left

Started Feb 2026

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Feb 2026Jan 2029

First Submitted

Initial submission to the registry

January 21, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 25, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

February 25, 2026

Status Verified

January 1, 2026

Enrollment Period

1.9 years

First QC Date

January 21, 2026

Last Update Submit

February 20, 2026

Conditions

Valve Disease, HeartAtrial Fibrillation (AF)Valve Replacement SurgeryAortic Valve SurgeryMitral Valve AnnuloplastyMitral Valve RepairMitral Valve Surgery

Keywords

anticoagulationbioprostheticsatrial fibrillationmitral valve repairaortic valve repairApixabanWarfarin

Outcome Measures

Primary Outcomes (2)

  • Major Bleeding

    Major bleeding defined as bleeding that results in death and/or symptomatic bleeding in a critical area or organ, bleeding into a surgical site requiring reoperation, bleeding leading to hospitalization (including presentation to an acute care facility without overnight stay) and/or bleeding that causes a drop in the hemoglobin level of 20g/L or more or that which requires the transfusion of ≥2 units of packed red blood cells or whole blood (as defined by the International Society of Thrombosis and Hemostasis)

    3 months

  • Death and/or thromboembolic complications

    Stroke Myocardial infarction Intracardiac thrombosis Systemic embolism Deep vein thrombosis Pulmonary embolism

    3 months

Secondary Outcomes (4)

  • Minor Bleeding

    3 months

  • Quality of Life - EQ-5D-5L

    3 months

  • Patient Satisfaction with Anticoagulant treatment

    3 months

  • Pleural or pericardial effusion requiring drainage

    3 months

Study Arms (2)

Apixaban

ACTIVE COMPARATOR

Patients in the intervention group will receive Apixaban at doses recommended for the indication, adjusted for their renal function is required.

Drug: Apixaban

Warfarin

PLACEBO COMPARATOR

Patients in the control group will receive VKA once daily; the individual dose will be titrated to achieve a guideline-recommended INR range.

Drug: Warfarin

Interventions

ApixabanDRUG

Patients in the intervention group will receive Apixaban at doses recommended for the indication, adjusted for their renal function is required.

Apixaban
WarfarinDRUG

Patients in the control group will receive VKA once daily; the individual dose will be titrated to achieve a guideline-recommended INR range.

Warfarin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

"E.Meshalkin National Medical Research Center" of the Ministry of Health of the Russian Federation

Novosibirsk, Russia

Location

MeSH Terms

Conditions

Heart Valve DiseasesAtrial Fibrillation

Interventions

apixabanWarfarin

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesArrhythmias, CardiacPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Alexander Afanasyev

CONTACT

+7 (383) 347-60-99a_afanasyev@meshalkin.ru

Maria Agarkova

CONTACT

agarkova_m@meshalkin.ru

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2026

First Posted

February 25, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2029

Last Updated

February 25, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)