Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2025-12-24 @ 3:45 PM
Study NCT ID:
NCT06738992
Status:
RECRUITING
Last Update Posted:
2024-12-18
First Post:
2024-12-06
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Effectiveness of Early Aspirin Administration After Mitral Valve Repair
Sponsor:
Guangdong Provincial People's Hospital
Organization:
Study Overview
Official Title:
Safety and Effectiveness of Early Aspirin Administration After Mitral Valve Repair: a Prospective, Non-inferiority, Randomized Controlled Clinical Trial Protocol
Status:
RECRUITING
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: