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| Name | Class |
|---|---|
| Chinese Academy of Medical Sciences | OTHER |
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This prospective, randomized, open-label study aims to evaluate the efficacy and safety of low-dose colchicine (0.5 mg daily) in reducing transcatheter heart valve (THV) thrombosis in patients after TAVR. Participants will be randomly assigned to either receive colchicine plus standard care or standard care alone for 12 months. The primary goal is to compare the rate of valve thrombosis between the two groups using 4D-CT imaging at one year. Additionally, the study will evaluate the treatment's impact on clinical outcomes and its overall safety profile.
To ensure balance between the two groups of patients in key prognostic factors, stratified randomization will be used. Stratification factors include: (1) type of implanted prosthetic valve (bulbar valve/self-expanding valve); (2) postoperative baseline antithrombotic regimen (antiplatelet therapy/anticoagulation therapy). Within each stratum, block randomization will be performed using a computer-generated random sequence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colchicine Group | Experimental | 0.5 mg once daily (QD) orally for 12 months, starting after successful TAVR and stabilization before discharge, on top of standard care. |
|
| Conventional Treatment | Active Comparator | Standard pharmacological management and long-term postoperative care according to current clinical guidelines and expert consensus for TAVR patients, without the use of colchicine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine | Drug | Colchicine 0.5 mg orally once daily for 12 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Transcatheter Heart Valve (THV) Thrombosis | Assessed via 4D-CT imaging to identify leaflet thickening or reduced leaflet motion | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Composite Endpoint: Including stroke, rehospitalization for heart failure, valve dysfunction, and all-cause mortality | Clinical Composite Endpoint: Including stroke, rehospitalization for heart failure, valve dysfunction, and all-cause mortality within 1 year | 1 month, 1 year |
| Dynamic Changes in Inflammatory/Coagulation Biomarkers |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yunqing Ye, MD, PhD | Contact | 8613699282532 | judia8510@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College | Beijing | 100037 | China |
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| Standard Care |
| Other |
Standard pharmacological management and long-term postoperative care according to current clinical guidelines and expert consensus for TAVR patients |
|
Dynamic Changes in Inflammatory/Coagulation Biomarkers: Changes in blood markers from baseline to 1 month and 1 year post-TAVR |
| 1 month, 1 year |
| Safety Evaluation: Incidence of adverse drug reactions and laboratory abnormalities | Adverse drug reactions: gastrointestinal symptoms (e.g., nausea, diarrhea, vomiting), myalgia, neuritis, skin rash, gout, hospitalization due to infection, new-onset malignancy, etc. Laboratory abnormalities: white blood cell count, absolute neutrophil count, liver and renal function, creatine kinase, etc. | 1 month, 1 year |
| ID | Term |
|---|---|
| D003078 | Colchicine |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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