Safety and Effectiveness of Early Aspirin Administration After Mitral Valve Repair

Phase 4

Recruiting

• Conditions: Mitral Valve Repair Surgery
• Interventions: Drug: Warfarin; Drug: Aspirin

• Registration Number: NCT06738992
• Lead Sponsor: Guangdong Provincial People's Hospital

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.

Study Timeline

• Status Verified: 2024-11
• Study Start: 2024-11-14
• Study First Submitted: 2024-12-06
• Study First Submitted QC: 2024-12-12
• Last Update Submitted: 2024-12-12
• Study First Posted: 2024-12-18
• Last Update Posted: 2024-12-18
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 384

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Warfarin Group	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.
Aspirin Group	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.

Primary Outcome Measures

Name	Time	Method
Clinical thromboembolic events	From enrollment to the end of treatment at 12 weeks	Clinical thromboembolic events are defined as stroke, myocardial infarction, symptomatic valve thrombosis, systemic embolism, deep venous thrombosis, or pulmonary embolism.
Asymptomatic intracardiac thrombosis	From enrollment to the end of treatment at 12 weeks	Asymptomatic intracardiac thrombosis is defined as subclinical leaflet thrombosis or intracavitary thrombus detected by cardiac computed tomography (CT) or echocardiography within 12 weeks postoperatively. Subclinical leaflet thrombosis is defined as leaflet thickening with reduced leaflet motion and at least moderate (reduction \>50%) valve area obstruction, demonstrated by cardiac CT, with a lesser degree of leaflet thinning.
Death due to cardiovascular causes or thromboembolic events	From enrollment to the end of treatment at 12 weeks
Major bleeding	From enrollment to the end of treatment at 12 weeks	Fatal bleeding; and/or symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, or pericardial or intramuscular bleeding with compartment syndrome; and/or bleeding resulting in a decrease in hemoglobin level by 3.0 g/dL。

Secondary Outcome Measures

Name	Time	Method
postoperative length of hospital stay	From enrollment to the end of treatment at 12 weeks	from the day of surgery to the first discharge
International normalized ratio at the time of thromboembolic or bleeding events	From enrollment to the end of treatment at 12 weeks
CHA2DS2-VASc scores	From enrollment to the end of treatment at 12 weeks	The CHA2DS2-VASC score is a risk stratification tool for assessing the likelihood of stroke in patients with non-valvular atrial fibrillation. The maximum score is 9, and the minimum score is 0.A lower CHA2DS2-VASC score is generally considered better.
HAS-BLED scores	From enrollment to the end of treatment at 12 weeks	The HAS-BLED score is a scoring system used to predict the risk of bleeding in patients with atrial fibrillation undergoing anticoagulant therapy. Its full name is the "Hemorrhagic risk in Atrial fibrillation patients on anti-coagulation therapy using European League Against Rheumatism (EULAR) criteria, Bleeding Academic Research Consortium (BARC) definitions" score system, often abbreviated as HAS-BLED.The maximum score is 9, and the minimum score is 0.A lower HAS-BLED score is generally considered better.

Trial Locations

Locations (1)

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China