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Design and Rationale of the COLT Study

Study acronym: COLT
StatusNot Yet Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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
(from sponsor)		 Venous Thrombosis Deep (Limbs), Post-thrombotic Syndrome, Venous Thromboembolism (VTE), Venous Insufficiency
Related terms Inflammation, Postthrombotic Syndrome, Venous Insufficiency, Venous Thromboembolism, Venous Thrombosis
Enrollment 940 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov