Colchicine to Quench the Inflammatory Response After Deep Vein Thrombosis (The Conquer-DVT Pilot Trial)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Colchicine 0.5 mg po, Placebo 0.5 mg po.
- Who it may be relevant to
- Registry conditions: Venous Thromboembolism. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Colchicine to Quench the Inflammatory Response After Deep Vein Thrombosis: A Randomized Controlled Pilot Trial
Overview
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).
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).
Interventions
- Drug Colchicine 0.5 mg po
Colchicine 0.5 mg po once daily for 180 days. - Drug Placebo 0.5 mg po
Placebo 0.5 mg po once daily for 180 days.
Primary outcome measures
- Pilot Trial Primary Outcome: Recruitment Rate [Time frame: 12 months]
- Full-Scale Trial Primary Outcome: Post Thrombotic Syndrome [Time frame: 180 days]
Secondary outcome measures (12)
- Pilot Trial Secondary Outcome: Eligibility Rate [Time frame: 12 months]
- Pilot Trial Secondary Outcome: Consent Rate [Time frame: 12 months]
- Pilot Trial Secondary Outcome: Retention Rate [Time frame: 12 months]
- Pilot Trial Secondary Outcome: Study Completion Rate [Time frame: 12 months]
- Pilot Trial Secondary Outcome: Adherence Rate [Time frame: 12 months]
- Pilot Trial Secondary Outcome: Reasons for declining participation [Time frame: 12 months]
- Full-Scale Trial Secondary Outcome: Post Thrombotic Syndrome [Time frame: 365 days]
- Full-Scale Trial Secondary Outcome: Severe Post Thrombotic Syndrome [Time frame: 180 and 365 days]
- Full-Scale Trial Secondary Outcome: Severity of Post Thrombotic Syndrome [Time frame: 180 and 365 days]
- Full-Scale Trial Secondary Outcome: Patient Reported VILLALTA Scale [Time frame: 180 and 365 days]
- Full-Scale Trial Secondary Outcome: Recurrent Venous Thromboembolism [Time frame: 180 and 365 days]
- Full-Scale Trial Secondary Outcome: Major Bleeding [Time frame: 180 and 365 days]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Canada · 4 centers
- The Ottawa Hospital General Campus — Ottawa
- Windsor Regional Hospital — Windsor
- Centre de recherche du Centre hospitalier de l'Université de Montréal — Montreal
- The Sir Mortimer B. Davis Jewish General Hospital — Montreal
Identifiers
NCT: NCT06440694 · CONQUER-DVT Pilot