Study of Daily Low-Dose Colchicine to Reduce Inflammation After Deep Vein Thrombosis in Adults

What this Trial Is About

Researchers are evaluating whether low-dose colchicine 0.5 mg daily can reduce the risk of post-thrombotic syndrome PTS in patients who have had a proximal lower extremity deep vein thrombosis DVT. This trial is a phase 3, double-blind, placebo-controlled, randomized pilot study designed to test the feasibility of a larger full-scale trial. The study is sponsored by the Ottawa Hospital Research Institute and focuses on patients who recently started anticoagulation therapy for acute symptomatic proximal lower extremity DVT. Participants will be randomly assigned to receive either colchicine 0.5 mg or a matching placebo once daily. Treatment begins within 7 days of starting anticoagulation and continues for approximately 180 days. The anticoagulant type, dose, and duration are determined by the treating physician. After completing the 180-day treatment period, the study drug will be discontinued, and ongoing care will be managed by the participants doctor. Participants will be observed for a total of 365 days from the start of treatment. During the study, participants will have various assessments to monitor their condition and response to treatment, including measuring post-thrombotic syndrome and related symptoms at 180 and 365 days. Researchers will also track recruitment, eligibility, consent, retention, adherence rates, and reasons for declining participation. Safety outcomes such as bleeding events, recurrent venous thromboembolism, overall mortality, and quality of life related to venous disease will be evaluated throughout the follow-up period.

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