A Randomized Controlled Trial of Anti-Inflammatory Therapy to Reduce Transcatheter Heart Valve Thrombosis After Transfemoral Transcatheter Aortic Valve Replacement
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Incidence of Transcatheter Heart Valve (THV) Thrombosis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with aortic stenosis aged 60-85 years.
- •Successful transfemoral TAVR (per VARC-3 criteria).
- •Voluntary participation with signed Informed Consent Form.
排除标准
- •Known hypersensitivity, allergy, or documented intolerance to colchicine.
- •Hematologic abnormalities defined as hemoglobin <80 g/L or white blood cell count <4.0 × 10⁹/L at screening.
- •Severe renal impairment defined as creatinine clearance <30 mL/min (calculated by the Cockcroft-Gault formula) or serum creatinine >2 × upper limit of normal (ULN).
- •Significant hepatic disease, including liver cirrhosis, chronic active hepatitis, hepatic injury (alanine aminotransferase >3 × ULN or total bilirubin >2 × ULN), or cholestasis.
- •Known history of bone marrow suppression.
- •Concomitant use of strong CYP3A4 or P-glycoprotein (P-gp) inhibitors, including but not limited to cyclosporine, amiodarone, clarithromycin, erythromycin, omeprazole, or verapamil.
- •Concomitant use of strong CYP3A4 or P-glycoprotein (P-gp) inducers, including but not limited to carbamazepine, phenobarbital, phenytoin, or rifampin.
- •Known neuromuscular disorders or creatine kinase (CK) >3 × ULN at screening.
- •Inflammatory bowel disease (Crohn's disease or ulcerative colitis) or chronic diarrhea.
- •Active malignancy or history of cancer.
- •Current use of systemic corticosteroids (oral or intravenous) or systemic immunosuppressive agents (topical or inhaled corticosteroids permitted).
- •Acute inflammatory condition or active viral infection at the time of enrollment.
- •Known galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- •Estimated life expectancy <1 year as determined by the investigator.
研究组 & 干预措施
Colchicine Group
0.5 mg once daily (QD) orally for 12 months, starting after successful TAVR and stabilization before discharge, on top of standard care.
干预措施: Colchicine (Drug)
Colchicine Group
0.5 mg once daily (QD) orally for 12 months, starting after successful TAVR and stabilization before discharge, on top of standard care.
干预措施: Standard Care (Other)
Conventional Treatment
Standard pharmacological management and long-term postoperative care according to current clinical guidelines and expert consensus for TAVR patients, without the use of colchicine.
干预措施: Standard Care (Other)
结局指标
主要结局
Incidence of Transcatheter Heart Valve (THV) Thrombosis
时间窗: 1 year
Assessed via 4D-CT imaging to identify leaflet thickening or reduced leaflet motion
次要结局
- Clinical Composite Endpoint: Including stroke, rehospitalization for heart failure, valve dysfunction, and all-cause mortality(1 month, 1 year)
- Dynamic Changes in Inflammatory/Coagulation Biomarkers(1 month, 1 year)
- Safety Evaluation: Incidence of adverse drug reactions and laboratory abnormalities(1 month, 1 year)