Colchicine to Quench the Inflammatory Response After Deep Vein Thrombosis (The Conquer-DVT Pilot Trial)

Phase 3RecruitingNCT06440694

Ottawa Hospital Research Institute150 enrolled

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).

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

150

Conditions

Venous Thromboembolism

Interventions

Colchicine 0.5 mg poDRUG

Colchicine 0.5 mg po once daily for 180 days.

Placebo 0.5 mg poDRUG

Placebo 0.5 mg po once daily for 180 days.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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: 1. History of an allergic reaction or significant sensitivity to colchicine. 2. Requirement of colchicine for other indications. 3. 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. 4. Known or suspected, recent (\<30 days) or active infections (acute or chronic). 5. History of cirrhosis, chronic active hepatitis, or severe liver disease. 6. Recent (\<30 days) or chronic use of systemic (oral, intravenous) immunosuppressive drugs (including but not limited to steroids, tumor necrosis factor-alpha blockers, cyclosporine). 7. Known active cancer. 8. 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. 9. Pregnancy, breast feeding or may be considering pregnancy during the study period or women of childbearing potential unwilling to use appropriate contraception during sex; 10. The use of medication with known drug-to-drug interactions (including but not limited to erythromycin or clarithromycin). 11. Unable or unwilling to provide consent.

Locations (3)

The Ottawa Hospital General Campus

Ottawa, Ontario, Canada

RECRUITING

Centre de recherche du Centre hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

RECRUITING

The Sir Mortimer B. Davis Jewish General Hospital

Montreal, Quebec, Canada

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Pilot Trial Primary Outcome: Recruitment Rate

Mean number of participants recruited per site per month

Time frame: 12 months

Full-Scale Trial Primary Outcome: Post Thrombotic Syndrome

VILLALTA scale score ≥5 signifies clinically meaningful Post Thrombotic Syndrome

Time frame: 180 days

Secondary Outcomes

Pilot Trial Secondary Outcome: Eligibility Rate

Proportion of screened patients who are eligible

Time frame: 12 months

Pilot Trial Secondary Outcome: Consent Rate

Proportion of eligible patients who provide consent

Time frame: 12 months

Pilot Trial Secondary Outcome: Retention Rate

Proportion of participants retained at follow-up

Time frame: 12 months

Pilot Trial Secondary Outcome: Study Completion Rate

Proportion of participants who completed all study procedures

Time frame: 12 months

Pilot Trial Secondary Outcome: Adherence Rate

Adherence to study drug measured by pill count at the end of follow-up

Time frame: 12 months

Pilot Trial Secondary Outcome: Reasons for declining participation

Time frame: 12 months

Central Contacts

Marc Carrier, MD,MSc,FRCPC

CONTACT

6137378899 mcarrier@toh.ca

Data from ClinicalTrials.gov

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