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Tests treatment safety and results for Mitral Valve Repair Surgery
Official title Safety and Effectiveness of Early Aspirin Administration After Mitral Valve Repair
ClinicalTrials.gov ID: NCT06738992
What this study is testing
What is Aspirin?
Aspirin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for mitral valve repair surgery.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join 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...
- 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...
- Patients who voluntarily participate in this study, have signed a written informed consent form, and are willing to comply with follow-up procedures.
You likely can't join 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...
- 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;
See the full eligibility 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...
- 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...
- Patients who voluntarily participate in this study, have signed a written informed consent form, and are willing to comply with follow-up procedures.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.