NCT06738992

Safety and Effectiveness of Early Aspirin Administration After Mitral Valve Repair

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 384 (estimated)
• Sponsor: Guangdong Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study compares the efficacy and safety of two different antithrombotic drugs, warfarin and aspirin, in early application after mitral valve repair (MVRep). The objective is to verify whether the type of antithrombotic therapy affects clinical outcomes and the incidence of thromboembolic and bleeding complications within 3 months after MVRep, and to provide safe and effective antithrombotic treatment options for patients undergoing MVRep.

Detailed description

Patients were randomly assigned in a 1:1 ratio to two groups: the Warfarin Group and the Aspirin Group. Warfarin Group: Anticoagulation therapy was initiated on the second day after surgery, starting at 4.5 mg once nightly, with adjustments made based on changes in the INR value. Aspirin Group: Antiplatelet therapy was initiated on the second day after surgery with oral administration of Aspirin Enteric-coated Tablets (Bayer Aspirin) at a dose of 100 mg once daily. For all patients, antithrombotic therapy was continued for at least 3 months post-surgery. Patients were scheduled for outpatient visits at 1, 4, 8, and 12 weeks following the surgical intervention.

Conditions

• Mitral Valve Repair Surgery

Interventions

Type	Name	Description
DRUG	Aspirin	Antiplatelet therapy was initiated on the second day after surgery with oral administration of Aspirin Enteric-coated Tablets (Bayer Aspirin) at a dose of 100 mg once daily.
DRUG	Warfarin	Anticoagulation therapy was initiated on the second day after surgery, starting at 4.5 mg once nightly, with adjustments made based on changes in the INR value.

Timeline

• Start date: 2024-11-14
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2024-12-18
• Last updated: 2024-12-18

Locations

1 site across 1 country: China