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The effect of vitamin K antagonists on the risk of embolism and major bleeding in patients after mitral valve repair

The effect of vitamin K antagonists on the risk of embolism and major bleeding in patients after mitral valve repair—A Double-Blind Randomized Controlled Trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112354
Enrollment
Unknown
Registered
2025-11-12
Start date
2025-07-29
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Degenerative Mitral Regurgitation

Interventions

VKA group:Postoperative oral administration of warfarin, initiated at 2.5 mg once daily (QD), with subsequent dose adjustments guided by INR monitoring to maintain a target INR range of 1.8–2.5.
Non-VKA group:Patients in the VKA group will receive enteric-coated aspirin at a maintenance dose of 20 mg orally once daily for three consecutive months postoperatively

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with isolated degenerative mitral regurgitation at West China Hospital of Sichuan University, aged over 18 years, and scheduled to undergo isolated mitral valve repair. 2. All patients underwent preoperative cardiac function assessment and echocardiography. Preoperative cardiac function (NYHA classification) was Class I–III, and all patients had red blood cell and platelet counts within normal ranges.

Exclusion criteria

Exclusion criteria: 1. Patients aged 70 years or older. 2. Patients with a history of stroke, transient ischemic attack (TIA), atrial fibrillation, deep vein thrombosis (DVT), pulmonary embolism, or gastrointestinal or genitourinary bleeding. 3. Patients with severe hepatic or renal dysfunction. 4. Patients who developed post-cardiac surgery complications, including cerebral infarction, transient ischemic attack, atrial fibrillation, or major bleeding events. 5. Patients with left atrial enlargement and/or heart function classified as NYHA Class III or higher.

Design outcomes

Primary

MeasureTime frame
Incidence of thromboembolic events;Incidence of major bleeding events;

Secondary

MeasureTime frame
All-cause mortality;Rehospitalization rate;Reoperation rate (valve-related complications);NYHA functional class change;Left ventricular ejection fraction (LVEF);

Countries

China

Contacts

Public ContactLiang Weitao

West China Hospital, Sichuan University

liang-weitao@qq.com+86 185 8371 2661

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026