Safety and Effectiveness of Early Aspirin Administration After Mitral Valve Repair

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

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.

Study Overview

• Status: Recruiting
• Conditions: Mitral Valve Repair Surgery
• Intervention / Treatment: Drug: Warfarin; Drug: Aspirin

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 Type: Interventional
• Enrollment (Estimated): 384
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Huanlei Huang Phd; Phone Number: 765-714-9765; Email: hhuanlei@hotmail.com
• Study Contact Backup: Name: Shanwen Pang BD; Email: mrpangsw@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510145
      • Recruiting
      • Guangdong Provincial People's Hospital
      • Contact: Huanlei Huang Phd; Phone Number: 765-714-9765; Email: hhuanlei@hotmail.com
      • Contact: Shanwen Pang BD; Email: mrpangsw@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical thromboembolic events	Clinical thromboembolic events are defined as stroke, myocardial infarction, symptomatic valve thrombosis, systemic embolism, deep venous thrombosis, or pulmonary embolism.	From enrollment to the end of treatment at 12 weeks
Asymptomatic intracardiac thrombosis	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.	From enrollment to the end of treatment at 12 weeks
Death due to cardiovascular causes or thromboembolic events		From enrollment to the end of treatment at 12 weeks
Major bleeding	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。	From enrollment to the end of treatment at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative length of hospital stay	from the day of surgery to the first discharge	From enrollment to the end of treatment at 12 weeks
International normalized ratio at the time of thromboembolic or bleeding events		From enrollment to the end of treatment at 12 weeks
CHA2DS2-VASc scores	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.	From enrollment to the end of treatment at 12 weeks
HAS-BLED scores	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.	From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 6, 2024
• First Submitted That Met QC Criteria: December 12, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Aspirin; Warfarin; mitral valve repair surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Fibrin Modulating Agents; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Antipyretics; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Fibrinolytic Agents; Platelet Aggregation Inhibitors; Anticoagulants; Aspirin; Warfarin
• Other Study ID Numbers: KY2024-767-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Baseline Characteristics, Outcome Measures, Adverse Events and so on
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No