Mitral Valve Repair SurgeryPhase 4NCT06738992
Safety and Effectiveness of Early Aspirin Administration After Mitral Valve Repair
A Phase 4 study testing Aspirin and Warfarin in people with Mitral Valve Repair Surgery, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Mitral Valve Repair Surgery
- What is being tested?
- Aspirin and Warfarin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 1 siteChina
- Study dates
- 14 Nov 2024to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Shanwen Pang BD contact
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510145
Huanlei Huang Phd, 765-714-9765, hhuanlei@hotmail.com
Shanwen Pang BD, mrpangsw@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Mitral Valve Repair Surgery
- Keywords
- mitral valve repair surgery, Warfarin, Aspirin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
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.
WarfarinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical thromboembolic events
Clinical thromboembolic events are defined as stroke, myocardial infarction, symptomatic valve thrombosis, systemic embolism, deep venous thrombosis, or pulmonary embolism.
Measured: 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.
Measured: From enrollment to the end of treatment at 12 weeks
Death due to cardiovascular causes or thromboembolic events
Measured: 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。
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (4)
postoperative length of hospital stay
from the day of surgery to the first discharge
Measured: From enrollment to the end of treatment at 12 weeks
International normalized ratio at the time of thromboembolic or bleeding events
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start14 Nov 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve Repair SurgeryStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738992
- Sponsor's protocol ID
- KY2024-767-02
- Status last verified
- Nov 2024
- First submitted
- 6 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Baseline Characteristics, Outcome Measures, Adverse Events and so on
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Early Aspirin Administration After Mitral Valve Repair: a Prospective, Non-inferiority, Randomized Controlled Clinical Trial Protocol
- ClinicalTrials.gov ID
- NCT06738992
- Acronym / sponsor ID
- KY2024-767-02
- Conditions
- Mitral Valve Repair Surgery
- Keywords
- mitral valve repair surgery, Warfarin, Aspirin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 14 Nov 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Warfarin Group | Active comparator | Drug: WarfarinAnticoagulation 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 | Experimental | Drug: AspirinAntiplatelet 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AspirinAntiplatelet 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 Group |
| WarfarinAnticoagulation 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 Group |
Primary outcome
Clinical thromboembolic events
Time frame: From enrollment to the end of treatment at 12 weeks
Clinical thromboembolic events are defined as stroke, myocardial infarction, symptomatic valve thrombosis, systemic embolism, deep venous thrombosis, or pulmonary embolism.
Asymptomatic intracardiac thrombosis
Time frame: From enrollment to the end of treatment at 12 weeks
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.
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
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。
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: Yes. Baseline Characteristics, Outcome Measures, Adverse Events and so on
Related trials for Mitral Valve Repair Surgery
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PRECISE-AFMR I: Transcatheter Mitral Valve Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation in Patients at High Surgical Risk
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PRIMARY Ancillary Substudy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shanwen Pang BD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin and Warfarin in people with Mitral Valve Repair Surgery, run by Guangdong Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huanlei Huang Phd (765-714-9765, hhuanlei@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical thromboembolic events (time frame: From enrollment to the end of treatment at 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.