2025-521836-12-00招募中2 期
Colchicine to Quench the Inflammatory Response after Deep Vein Thrombosis: The CONQUER-DVT Randomized Controlled Trial
Universita' Degli Studi G. D'Annunzio Di Chieti5 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2026年2月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 122
- 试验地点
- 5
- 主要终点
- PTS (Villalta score ≥5) at 12 months
研究概览
简要总结
To evaluate the safety and efficacy of low-dose colchicine 0.5 mg versus placebo once daily in reducing the risk of Post-thrombotic syndrome (PTS) in patients with proximal lower-extremity deep vein thrombosis (DVT).
研究设计
- 分配方式
- Randomized
- 主要目的
- Follow-up
- 盲法
- Double (Subject, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •First, acute, symptomatic proximal (popliteal or more proximal vein) objectively-confirmed DVT of the lower extremity
- •Written informed consent
排除标准
- •Any contraindication to colchicine as per summary of product characteristics (SmPC)
- •Known active cancer
- •Any of the following as measured within the past 1-3 months or at screening: alanine or aspartate aminotransferase >3x upper limit of normal (ULN); total bilirubin >2x ULN; creatinine clearance, calculated using Cockcroft-Gault formula, <30 mL/min
- •Presence of HIV infection
- •Hypersensitivity to the active substance or to any of the excipients
- •Participation in another interventional trial within the past 30 days or 5 half-lives of the study drug, whichever is longer
- •Unwilling to provide consent
- •Pregnancy, breastfeeding or may be considering pregnancy during the study period or women of childbearing potential unwilling to use appropriate contraception during sex
- •Use of medications with known significant drug-to-drug interactions with colchicine including but not limited to erythromycin or clarithromycin
- •History of an allergic reaction or significant sensitivity to colchicine
- •Requirement of colchicine for other indications
- •Active or chronic diarrhoea, or documented inflammatory bowel disease (i.e., Crohn’s disease or ulcerative colitis), collagenous colitis/irritable bowel syndrome, or existing blood dyscrasias
- •Known or suspected, recent (<30 days) or active infections (acute or chronic)
- •History of cirrhosis, chronic active hepatitis, or severe liver disease
- •Recent (<30 days) or chronic use of systemic (oral, intravenous) immunosuppressive drugs (including but not limited to steroids, tumor necrosis factor-alpha blockers, cyclosporine)
研究组 & 干预措施
COLCHICINA LIRCA 0.5 mg compresse
Test
干预措施: COLCHICINA LIRCA 0.5 mg compresse (Drug)
Placebo Colchicine Tablets: lactose, extra-fine sugar, spray-dried acacia, and, magnesium stearate
Placebo
干预措施: Placebo Colchicine Tablets: lactose, extra-fine sugar, spray-dried acacia, and, magnesium stearate (Drug)
结局指标
主要结局
PTS (Villalta score ≥5) at 12 months
PTS (Villalta score ≥5) at 12 months
次要结局
- Proportion of patients with PTS (Villalta score ≥5) at 6 months
- Proportion of patients according to the following PTS severity categories based on Villalta score category: mild (Villalta Score 5-9), moderate (Villalta score 10-14), severe (Villalta score ≥15 or presence of ulcer) at 6 and 12 months
- Mean Villalta score and mean change from baseline (based on continuous Villalta score) at 6 and 12 months to estimate the severity of PTS
- Incidence rate of recurrent venous thromboembolism (VTE) during follow-up (up to 12 months)
- Incidence rate of arterial thromboembolism (ATE) during follow-up (up to 12 months)
- Incidence rate of composite of adverse vascular events (comprising PTS, recurrent VTE, ATE) during follow-up (up to 12 months)
- Incidence rate of major bleeding (as per International Society of Thrombosis and Haemostasis (ISTH) definition) during follow-up (up to 12 months)
- Incidence rate of clinically relevant non-major bleeding (as per ISTH definition) during follow-up (up to 12 months)
- All-cause mortality rate
- Mean changes in patient-reported outcome measures (PROMs) from baseline to 6 and 12 months as assessed by functional scales (Patient reported Villalta-scale - PRV, Post-venous thromboembolism functional status - PVFS), and generic health-related and disease specific QOL questionnaires (EuroQoL-EQ-5D-5L, VEINES QOL/Sym, PEmb-QoL)
- Safety endpoints: 1.Number and incidence rate of gastrointestinal adverse events that result in study drug discontinuation 2.Number and incidence rate of muscle pain episodes that results in study drug discontinuation 3.Number and incidence rate of infections episodes leading to hospitalization. Other: renal insufficiency; neutropenia and/or neuropathy leading to study drug discontinuatio
研究者
Di Nisio
Scientific
Universita' Degli Studi G. D'Annunzio Di Chieti
研究点 (5)
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