Safety and Effectiveness of Early Aspirin Administration After Mitral Valve Repair

Recruiting now · Phase 4

Conditions studied: Mitral Valve Repair Surgery

In brief

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.

Key facts

Study ID

NCT06738992

Run by

Guangdong Provincial People's Hospital

People needed

384

Starts

2024-11-14

Expected to finish

2027-12-31

Last updated by the study team

2024-12-18

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

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

Full record on ClinicalTrials.gov

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