Clinical Trial

Design and Rationale of the COLT Study

Study acronym: COLT
Not Yet Recruiting Phase 3
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Summary
Deep vein thrombosis (DVT) is a condition in which a blood clot forms in the deep veins of the leg and can lead to long-term problems such as leg pain, swelling, and reduced quality of life. Standard treatment with blood-thinning medication lowers the risk of complications, but some patients still develop long-term damage to the veins. Inflammation is thought to play an important role in these complications. This study will evaluate whether adding colchicine, an anti-inflammatory medication already used for other conditions, to standard anticoagulant therapy can improve outcomes in patients with acute DVT. Participants will be randomly assigned to receive either colchicine or a placebo, in addition to usual blood-thinning treatment, and will be followed for one year. The main goal of the study is to determine whether colchicine reduces the risk of developing long-term vein problems after DVT. The study will also assess the risk of new blood clots, vein recovery, quality of life, and the safety of colchicine treatment.
Trial Details
NCT Number NCT07432529
Lead Sponsor Azienda Sanitaria Locale ASL 6, Livorno
Conditions Venous Thrombosis Deep (Limbs), Post-thrombotic Syndrome, Venous Thromboembolism (VTE), Venous Insufficiency
Enrollment 940 participants
Start Date 2026-06-01
Primary Completion 2027-06-01 (estimated)
Study Completion 2027-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-02-25