Colchicine to Quench the Inflammatory Response After Deep Vein Thrombosis (The Conquer-DVT Pilot Trial)
- Conditions
- Venous Thromboembolism
- Interventions
- Drug: Placebo 0.5 mg po
- Registration Number
- NCT06440694
- Lead Sponsor
- Ottawa Hospital Research Institute
- Brief Summary
Purpose of the pilot trial:
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).
- Detailed Description
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).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 150
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Arm : Placebo Placebo 0.5 mg po 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. Experimental Arm: Colchicine Colchicine 0.5 mg po 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.
- Primary Outcome Measures
Name Time Method Full-Scale Trial Primary Outcome: Post Thrombotic Syndrome 180 days V. score ≥5
Pilot Trial Primary Outcome: Recruitment Rate 12 months Mean number of participants recruited per site per month
- Secondary Outcome Measures
Name Time Method Full-Scale Trial Secondary Outcome: Post Thrombotic Syndrome 365 days V. score ≥5
Full-Scale Trial Secondary Outcome: Recurrent Venous Thromboembolism 180 and 365 days Full-Scale Trial Secondary Outcome: Recurrent Venous Thromboembolism
Full-Scale Trial Secondary Outcome: Clinically Relevant Non-Major Bleeding 180 and 365 days As per ISTH definition
Pilot Trial Secondary Outcome: Consent Rate 12 months Proportion of eligible patients who provide consent
Pilot Trial Secondary Outcome: Study Completion Rate 12 months Proportion of participants who completed all study procedures
Pilot Trial Secondary Outcome: Reasons for declining participation 12 months Pilot Trial Secondary Outcome: Reasons for declining participation
Full-Scale Trial Secondary Outcome: Severe Post Thrombotic Syndrome 180 and 365 days V. score ≥ 15 or presence of ulcer
Pilot Trial Secondary Outcome: Eligibility Rate 12 months Proportion of screened patients who are eligible
Pilot Trial Secondary Outcome: Retention Rate 12 months Proportion of participants retained at follow-up
Pilot Trial Secondary Outcome: Adherence Rate 12 months Adherence to study drug measured by pill count at the end of follow-up
Full-Scale Trial Secondary Outcome: Incremental Cost-Effectiveness Ratio (ICER) 180 and 365 days Full-Scale Trial Secondary Outcome: Incremental Cost-Effectiveness Ratio (ICER)
Full-Scale Trial Secondary Outcome: Severity of Post Thrombotic Syndrome 180 and 365 days Continuous V. score
Full-Scale Trial Secondary Outcome: Patient Reported V. Scale 180 and 365 days Full-Scale Trial Secondary Outcome: Patient Reported V. Scale
Full-Scale Trial Secondary Outcome: Overall Mortality 180 and 365 days Full-Scale Trial Secondary Outcome: Overall Mortality
Full-Scale Trial Secondary Outcome: Major Bleeding 180 and 365 days As per International Society on Thrombosis and Haemostasis (ISTH) definition
Full-Scale Trial Secondary Outcome: Venous disease Specific Quality of Life 180 and 365 days Scoring using VEINES-QOL/Sym
Full-Scale Trial Secondary Outcome: Health-Related Quality of Life 180 and 365 days Scoring using EuroQoL-EQ-5D-5L
Trial Locations
- Locations (1)
The Ottawa Hospital General Campus
🇨🇦Ottawa, Ontario, Canada