Safety and Effectiveness of Early Aspirin Administration After Mitral Valve Repair

Official title

Safety and Effectiveness of Early Aspirin Administration After Mitral Valve Repair: a Prospective, Non-inferiority, Randomized Controlled Clinical Trial Protocol

Overview

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.

Interventions

• Drug 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.
• Drug 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.

Primary outcome measures

• Clinical thromboembolic events [Time frame: From enrollment to the end of treatment at 12 weeks]
• Asymptomatic intracardiac thrombosis [Time frame: From enrollment to the end of treatment at 12 weeks]
• Death due to cardiovascular causes or thromboembolic events [Time frame: From enrollment to the end of treatment at 12 weeks]
• Major bleeding [Time frame: From enrollment to the end of treatment at 12 weeks]

Secondary outcome measures (4)

• postoperative length of hospital stay [Time frame: From enrollment to the end of treatment at 12 weeks]
• International normalized ratio at the time of thromboembolic or bleeding events [Time frame: From enrollment to the end of treatment at 12 weeks]
• CHA2DS2-VASc scores [Time frame: From enrollment to the end of treatment at 12 weeks]
• HAS-BLED scores [Time frame: From enrollment to the end of treatment at 12 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

China · 1 center

• Guangdong Provincial People's Hospital — Guangzhou

Identifiers

NCT: NCT06738992 · KY2024-767-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗