Safety and Effectiveness of Early Aspirin Administration After Mitral Valve Repair

NCT06738992 | Recruiting Phase 4 DMC

• 1 other identifier: KY2024-767-02
• Study Type: interventional
• Target: 384
• Locations: 1 country
• Sites: 1

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.

Conditions

Mitral Valve Repair Surgery

Keywords

mitral valve repair surgery; Warfarin; Aspirin

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• postoperative length of hospital stay

  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

  From enrollment to the end of treatment at 12 weeks

• HAS-BLED scores

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

Warfarin Group

ACTIVE COMPARATOR

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

Aspirin Group

EXPERIMENTAL

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

Interventions

Aspirin DRUG

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.

Aspirin Group

Warfarin DRUG

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.

Warfarin Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510145, China

RECRUITING

MeSH Terms

Interventions

Aspirin; Warfarin

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Huanlei Huang Phd

CONTACT

765-714-9765; hhuanlei@hotmail.com

Shanwen Pang BD

CONTACT

mrpangsw@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 18, 2024
• Study Start: November 14, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

CN (1)