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Condition / disease
Location
Status: Not yet recruiting

Design and Rationale of the COLT Study

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.

Participants needed: 940
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Azienda Sanitaria Locale ASL 6, LivornoUpdated: Feb 25, 2026
Eligibility criteria

Age ≥18 years at the time of screening. [+5]

History of prior DVT in the same limb. [+14]