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NCT07432529: COLT

Design and Rationale of the COLT Study

Not yet recruiting Phase 3 Last updated 25 February 2026
What this trial tests

Phase 3 trial testing Colchicine 0.5 MG Oral Tablet in Venous Thrombosis Deep (Limbs) in 940 participants. Not yet recruiting.

Timeline
1 June 2026
Primary endpoint
1 June 2027
1 June 2027

Quick facts

Lead sponsorAzienda Sanitaria Locale ASL 6, Livorno
PhasePhase 3
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposeprevention
Enrollment940
Start date1 June 2026
Primary completion1 June 2027
Estimated completion1 June 2027

Drugs / interventions tested

Conditions studied

Sponsor

Azienda Sanitaria Locale ASL 6, Livorno

Who can join

18 and older, any sex, with Venous Thrombosis Deep (Limbs) or Post-thrombotic Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07432529.

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