Colchicine to Quench the Inflammatory Response After Deep Vein Thrombosis: A Randomized Controlled Pilot Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Pilot Trial Primary Outcome: Recruitment Rate
研究概览
简要总结
This trial seeks to assess the feasibility of a full-scale, double-blind, placebo-controlled, randomized trial assessing whether low-dose colchicine (0.5 mg daily) reduces the risk of post-thrombotic syndrome (PTS) in patients with proximal lower extremity deep vein thrombosis (DVT).
详细描述
Eligible and consenting patients will be randomized via a central web-based randomization system (1:1 ratio) to receive one tablet of colchicine 0.5 mg or identical matching placebo daily starting within 7 days of initiation of anticoagulation for acute, symptomatic, proximal lower extremity Deep Vein Thrombosis (DVT) for a treatment course of 180 days (+/- 7 days). Study drug will start within 24 hours of randomization. The type, dose, and duration of anticoagulant therapy : unfractionated heparin, Low Molecular Weight Heparin (LMWH), fondaparinux, Direct Oral Anticoagulation (DOAC) or Vitamin K Agonist (VKA) will be left to the discretion of the treating physician or local investigator. The study drug will be continued until the end of the treatment period (180 days +/- 7 days). All patients will be observed until the end of study follow-up (365 days +/- 7 days).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consenting patients 18 years of age or older with a first, acute, symptomatic proximal (popliteal vein or more proximal) objectively confirmed DVT of the lower extremity will be eligible to participate in the study.
排除标准
- •History of an allergic reaction or significant sensitivity to colchicine.
- •Requirement of colchicine for other indications.
- •Active or chronic diarrhea, or documented inflammatory bowel disease (i.e., Crohn's disease or ulcerative colitis), collagenous colitis or 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).
- •Known active cancer.
- •Any of the following as measured within the past 1-3 months or at screening: alanine, or aspartate aminotransferase >3 times the upper limit of normal, total bilirubin >2 times the upper limit of normal and a creatinine clearance by Cockcroft-Gault formula <30 mL/min.
- •Pregnancy, breast feeding or may be considering pregnancy during the study period or women of childbearing potential unwilling to use appropriate contraception during sex;
- •The use of medication with known drug-to-drug interactions (including but not limited to erythromycin or clarithromycin).
- •Unable or unwilling to provide consent.
研究组 & 干预措施
Control Arm : Placebo
Placebo 0.5 mg po once daily for 180 days. After the Day - 180 follow up, the study treatment will be discontinued and subsequent treatment will be at the discretion of the attending physician.
干预措施: Placebo 0.5 mg po (Drug)
Experimental Arm: Colchicine
Colchicine 0.5 mg po once daily for 180 days. After the Day - 180 follow up, the study treatment will be discontinued and subsequent treatment will be at the discretion of the attending physician.
干预措施: Colchicine 0.5 mg po (Drug)
结局指标
主要结局
Pilot Trial Primary Outcome: Recruitment Rate
时间窗: 12 months
Mean number of participants recruited per site per month
Full-Scale Trial Primary Outcome: Post Thrombotic Syndrome
时间窗: 180 days
VILLALTA scale score ≥5 signifies clinically meaningful Post Thrombotic Syndrome
Pilot Trial Primary Outcome: Recruitment Rate
时间窗: 12 months
Mean number of participants recruited per site per month
Full-Scale Trial Primary Outcome: Post Thrombotic Syndrome
时间窗: 180 days
VILLALTA scale score ≥5 signifies clinically meaningful Post Thrombotic Syndrome
次要结局
- Pilot Trial Secondary Outcome: Adherence Rate(12 months)
- Pilot Trial Secondary Outcome: Reasons for declining participation(12 months)
- Full-Scale Trial Secondary Outcome: Post Thrombotic Syndrome(365 days)
- Full-Scale Trial Secondary Outcome: Severe Post Thrombotic Syndrome(180 and 365 days)
- Full-Scale Trial Secondary Outcome: Recurrent Venous Thromboembolism(180 and 365 days)
- Full-Scale Trial Secondary Outcome: Clinically Relevant Non-Major Bleeding(180 and 365 days)
- Full-Scale Trial Secondary Outcome: Overall Mortality(180 and 365 days)
- Full-Scale Trial Secondary Outcome: Venous disease Specific Quality of Life(180 and 365 days)
- Full-Scale Trial Secondary Outcome: Health-Related Quality of Life(180 and 365 days)
- Full-Scale Trial Secondary Outcome: Incremental Cost-Effectiveness Ratio (ICER)(180 and 365 days)
- Pilot Trial Secondary Outcome: Consent Rate(12 months)
- Pilot Trial Secondary Outcome: Retention Rate(12 months)
- Pilot Trial Secondary Outcome: Study Completion Rate(12 months)
- Full-Scale Trial Secondary Outcome: Post Thrombotic Syndrome(365 days)
- Pilot Trial Secondary Outcome: Adherence Rate(12 months)
- Pilot Trial Secondary Outcome: Reasons for declining participation(12 months)
- Pilot Trial Secondary Outcome: Eligibility Rate(12 months)
- Pilot Trial Secondary Outcome: Consent Rate(12 months)
- Pilot Trial Secondary Outcome: Retention Rate(12 months)
- Pilot Trial Secondary Outcome: Study Completion Rate(12 months)
- Full-Scale Trial Secondary Outcome: Severe Post Thrombotic Syndrome(180 and 365 days)
- Full-Scale Trial Secondary Outcome: Severity of Post Thrombotic Syndrome(180 and 365 days)
- Full-Scale Trial Secondary Outcome: Patient Reported VILLALTA Scale(180 and 365 days)
- Full-Scale Trial Secondary Outcome: Recurrent Venous Thromboembolism(180 and 365 days)
- Full-Scale Trial Secondary Outcome: Major Bleeding(180 and 365 days)
- Full-Scale Trial Secondary Outcome: Clinically Relevant Non-Major Bleeding(180 and 365 days)
- Full-Scale Trial Secondary Outcome: Overall Mortality(180 and 365 days)
- Full-Scale Trial Secondary Outcome: Venous disease Specific Quality of Life(180 and 365 days)
- Full-Scale Trial Secondary Outcome: Health-Related Quality of Life(180 and 365 days)
- Full-Scale Trial Secondary Outcome: Incremental Cost-Effectiveness Ratio (ICER)(180 and 365 days)