Design and Rationale of the COLT Study (NCT07432529) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Design and Rationale of the COLT Study
940 participantsStarted 2026-06-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥18 years at the time of screening.
✓. Objectively confirmed first, symptomatic acute proximal lower-limb deep vein thrombosis (DVT), involving the popliteal vein or more proximal veins, diagnosed within the previous 48 hours.
✓. Planned initiation of standard anticoagulation therapy, including:
✓. Ability and willingness to provide written informed consent and comply with all study procedures.
Exclusion criteria
✕. History of prior DVT in the same limb.
✕. Known contraindications to anticoagulation or anticipated inability to comply with study procedures.
✕. Current use of colchicine or clinical indication requiring colchicine therapy.
✕. Known hypersensitivity or allergy to colchicine.
✕. Severe hepatic impairment, defined as ALT or AST \>3× upper limit of normal, or severe renal impairment (creatinine clearance \<30 mL/min).
What they're measuring
1
Post-thrombotic syndrome (PTS)
Timeframe: From the start of treatment to the 12-month follow-up visit
2
Recurrent venous thromboembolism.
Timeframe: From the start of treatment to the 12-month follow-up visit