Actively Recruiting
Safety and Effectiveness of Early Aspirin Administration After Mitral Valve Repair
Led by Guangdong Provincial People's Hospital · Updated on 2024-12-18
384
Participants Needed
1
Research Sites
163 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Effectiveness of Early Aspirin Administration After Mitral Valve Repair
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older, but not older than 85 years
- Successfully underwent mitral valve repair with implantation of a mitral annuloplasty ring
- May have had concurrent tricuspid valve repair, atrial septal defect repair, or myxoma removal
- Preoperative ECG showing sinus rhythm, or atrial fibrillation with low CHA2DS2-VASc-60 score or converted to sinus rhythm after ablation
- Willing to participate voluntarily, provide informed consent, and comply with follow-up
You will not qualify if you...
- Contraindications to heparin, warfarin, or aspirin
- Artificial valve replacement at other valve sites
- High risk of bleeding, including active bleeding, low platelets, low hemoglobin, recent cerebral hemorrhage, active peptic ulcer, or recent gastrointestinal bleeding
- Acute coronary syndrome within the last month
- Symptomatic stroke within the last 3 months
- Renal insufficiency with creatinine clearance below 30 mL/min or dialysis
- Moderate or severe liver impairment or liver disease with coagulation problems
- Active malignant tumors
- Planned surgery or treatment requiring stopping anticoagulants during the trial
- Pregnant or breastfeeding women, or those unwilling/unable to use contraception
- Participation in another drug trial within 6 months before screening
- Refusal to undergo follow-up
- Considered unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510145
Actively Recruiting
Research Team
H
Huanlei Huang Phd
CONTACT
S
Shanwen Pang BD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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