Safety and Effectiveness of Early Aspirin Administration After Mitral Valve Repair
NCT ID: NCT06738992
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
384 participants
INTERVENTIONAL
2024-11-14
2027-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
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
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
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
85 Years
ALL
No
Sponsors
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Guangdong Provincial People's Hospital
OTHER
Responsible Party
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Locations
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Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Huanlei Huang Phd
Role: primary
Shanwen Pang BD
Role: backup
Other Identifiers
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KY2024-767-02
Identifier Type: -
Identifier Source: org_study_id