COmparisoN of Anti-ThrombotiC Treatments Between Aspirin and Warfarin During InitiaL Six Months After Bioprosthetic Heart ValvE Replacement

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0011353

Enrollment

1058

Registered

2025-12-19

Start date

2026-06-05

Completion date

Unknown

Last updated

2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : aspirin : 100mg 1 tablet once daily for 6 months Vitamin K antagonist(warfarin) : Maintain an INR of 2.0 to 3.0 for 6 months

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged = 19 years with successful surgical bioprosthetic valve replacement 2. Bioprosthetic heart valve(using Resilia device: INSPIRIS or MITRIS RESILIA) in aortic or mitral valve positions, for a day postoperatively 3. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion criteria

Exclusion criteria: 1. Mechanical valve in any heart valve position 2. Previous hemorrhagic stroke within the last 3 months 3. Clinically overt stroke within the last 3 months 4. Current need for anticoagulation including, but not limited to, atrial fibrillation, deep vein thrombosis, or left ventricular apical aneurysm with thrombus 5. Unstable postoperative conditions at index point (i.e. requirement mechanical hemodynamix support, disabling complications, stroke [ischemic, embolic], hemorrhagic stroke) 6. Hypersensitivity to the main component or constituents of aspirin or vitamin K antagonist 7. Pregnant or lactating women 8. Current use of antiplatelet agents other than aspirin 9. Severe left ventricular dysfunction defined by ejection fraction <30%

Design outcomes

Primary

Measure	Time frame
Number of study participants who experienced a composite endpoint within 6 months	—

Secondary

Measure	Time frame
1. Each component of primary composite outcomes 2. A composite of death from any cause, stroke, systemic embolism, transient ischemic attack, and myocardial infarction at 6 months 3. Death from any cause at 6 months 4. Death from cardiovascular cause at 6 months Composite of stroke, systemic embolism, transient ischemic attack, and myocardial infarction at 6 months 5. Stroke at 6 months 6. Systemic embolism at 6 months 7. Transient ischemic attack at 6 months 8. Myocardial infarction at 6 months 9. Major bleeding (BARC-3 or 5) at 6 months 10. Valve thrombosis confirmed by TTE, TEE, Cinefluoroscopy or autopsy (By VARC criteria) 11. The parameters of echocardiography: Trans-valvular mean gradient, trans-valvular peak gradient, trans-valvular peak velocity and effective orifice arear (EOA) of the prosthetic valves.	—

Measure

Time frame

1. Each component of primary composite outcomes 2. A composite of death from any cause, stroke, systemic embolism, transient ischemic attack, and myocardial infarction at 6 months 3. Death from any cause at 6 months 4. Death from cardiovascular cause at 6 months Composite of stroke, systemic embolism, transient ischemic attack, and myocardial infarction at 6 months 5. Stroke at 6 months 6. Systemic embolism at 6 months 7. Transient ischemic attack at 6 months 8. Myocardial infarction at 6 months 9. Major bleeding (BARC-3 or 5) at 6 months 10. Valve thrombosis confirmed by TTE, TEE, Cinefluoroscopy or autopsy (By VARC criteria) 11. The parameters of echocardiography: Trans-valvular mean gradient, trans-valvular peak gradient, trans-valvular peak velocity and effective orifice arear (EOA) of the prosthetic valves.

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Countries

Korea, Republic of

Contacts

Public ContactJOON BUM KIM

Asan Medical Center

jbkim1975@amc.seoul.kr+82-2-3010-5416

Outcome results