Actively Recruiting

Phase 4
Age: 18Years - 85Years
All Genders
NCT06738992

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

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China, 510145

Actively Recruiting

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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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Safety and Effectiveness of Early Aspirin Administration After Mitral Valve Repair | DecenTrialz