Comparing aspirin and warfarin after mitral valve repair surgery

Safety and Effectiveness of Early Aspirin Administration After Mitral Valve Repair: a Prospective, Non-inferiority, Randomized Controlled Clinical Trial Protocol

This study is testing whether giving aspirin or warfarin right after mitral valve repair surgery helps patients stay safe and healthy in the months that follow.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 384 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Guangdong Provincial People's Hospital (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06738992 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of early administration of aspirin versus warfarin in patients who have undergone mitral valve repair surgery. Participants are randomly assigned to receive either aspirin or warfarin starting on the second day post-surgery, with the aim of assessing clinical outcomes and the incidence of thromboembolic and bleeding complications within three months. Follow-up visits are scheduled at 1, 4, 8, and 12 weeks after the surgery to monitor patient progress and medication effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 85 who have successfully undergone mitral valve plasty and meet specific preoperative ECG criteria.

Not a fit: Patients with contraindications to heparin or those not meeting the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide safer and more effective antithrombotic treatment options for patients recovering from mitral valve repair surgery.

How similar studies have performed: Previous studies have explored antithrombotic therapies in similar surgical contexts, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Individuals aged 18 years and above, but not exceeding 85 years;
* Patients who have successfully undergone mitral valve plasty with implantation of a mitral annuloplasty ring, with the option to undergo concurrent tricuspid valve plasty, atrial septal defect repair, or myxoma resection;
* Patients with preoperative electrocardiogram (ECG) showing sinus rhythm;
* Alternatively, patients with preoperative ECG showing atrial fibrillation (AF) rhythm, but who are male with a CHA2DS2-VASc-60 score of 0 or female with a score of 1; for patients with a CHA2DS2-VASc-60 score exceeding the aforementioned values but who have successfully converted to sinus rhythm following concurrent radiofrequency catheter ablation for AF;
* Patients who voluntarily participate in this study, have signed a written informed consent form, and are willing to comply with follow-up procedures.

Exclusion Criteria:

* Patients with contraindications to any of the following medications: heparin, warfarin, or aspirin;
* Patients who have undergone artificial valve replacement at other valve positions;
* Patients with a high risk of bleeding (including active bleeding, platelet count \<50×10\^9/L, hemoglobin \<8.0 g/dL, history of cerebral hemorrhage, active peptic ulcer, or history of gastrointestinal bleeding within the last 3 months);
* Patients with acute coronary syndrome within the last month;
* Patients with symptomatic stroke within the last 3 months;
* Patients with renal insufficiency and a creatinine clearance rate \<30 mL/min; Dialysis patients;
* Patients with moderate or severe hepatic impairment or liver disease with coagulation dysfunction: Child-Pugh score greater than B or bilirubin greater than or equal to 2 times the upper limit of normal (ULN) as defined by the center, and alanine aminotransferase (ALT), aspartate aminotransferase (AST), or serum alkaline phosphatase (ALP) levels greater than or equal to 3 times the ULN as defined by the center;
* Patients with active malignant tumors;
* Patients who are planned to undergo surgical intervention or treatment (including endoscopy) during the trial period that requires discontinuation of anticoagulants;
* Pregnant or lactating women, or fertile individuals unwilling or unable to use effective contraceptives;
* Patients who have participated in any drug clinical trial within the last 6 months prior to screening;
* Patients who refuse to undergo follow-up;
* Patients deemed unsuitable for participation in this study by the investigator.

Where this trial is running

Guangzhou, Guangdong

• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Huanlei Huang Phd

Conditions Mitral Valve Repair Surgery; mitral valve repair surgery; Warfarin; Aspirin