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NCT07432529

PHASE3

Design and Rationale of the COLT Study

Sponsor: Azienda Sanitaria Locale ASL 6, Livorno

View on ClinicalTrials.gov

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.

Official title: Design and Rationale of the COLT Study: a Multicentre, Randomised, Double-blind, Placebo-controlled Trial of COLchicine as Adjunctive Therapy to Standard Anticoagulation in Acute Proximal Deep Vein Thrombosis of the Lower Limbs

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

940

Start Date

2026-06-01

Completion Date

2027-06-01

Last Updated

2026-02-25

Healthy Volunteers

Conditions

Venous Thrombosis Deep (Limbs)Post-thrombotic Syndrome Venous Thromboembolism (VTE)Venous Insufficiency

Interventions

DRUG

Colchicine 0.5 MG Oral Tablet

Low-dose colchicine added to standard anticoagulant therapy for acute proximal deep vein thrombosis. Colchicine is administered 0.5 mg twice daily for the first month, then 0.5 mg once daily for the next five months. Participants are monitored for post-thrombotic syndrome, recurrent venous thromboembolism, vein recanalization, quality of life, and safety over 12 months.

DRUG

Placebo

Matching placebo administered alongside standard anticoagulant therapy on the same schedule as colchicine. Participants are monitored for the same outcomes and safety measures.

Inclusion Criteria: 1. Age ≥18 years at the time of screening. 2. 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. 3. Planned initiation of standard anticoagulation therapy, including: * Low-molecular-weight heparin (LMWH) bridging to vitamin K antagonists (VKA) or direct oral anticoagulants (DOACs), * DOAC monotherapy according to local guidelines, * Fondaparinux or other guideline-recommended regimens. Note: Standard anticoagulation regimens include dose reduction of apixaban or rivaroxaban at the sixth month, as per local practice. 4. Ability and willingness to provide written informed consent and comply with all study procedures. Exclusion Criteria: Participants meeting any of the following criteria will be excluded: 1. History of prior DVT in the same limb. 2. Known contraindications to anticoagulation or anticipated inability to comply with study procedures. 3. Current use of colchicine or clinical indication requiring colchicine therapy. 4. Known hypersensitivity or allergy to colchicine. 5. Severe hepatic impairment, defined as ALT or AST \>3× upper limit of normal, or severe renal impairment (creatinine clearance \<30 mL/min). 6. Active malignancy with an estimated life expectancy \<12 months. 7. History of active or chronic gastrointestinal disease that may interfere with colchicine tolerance, including: 1. Inflammatory bowel disease (Crohn's disease or ulcerative colitis), 2. Collagenous colitis, 3. Irritable bowel syndrome, 4. Chronic or recurrent diarrhea. 8. Recent (\<30 days) or ongoing use of systemic immunosuppressive therapy, including but not limited to corticosteroids, cyclosporine, or tumor necrosis factor-alpha inhibitors. 9. Pregnancy or breastfeeding, or unwillingness to use effective contraception during the study period. 10. Concomitant use of strong CYP3A4 inhibitors or P-glycoprotein inhibitors contraindicated with colchicine. 11. Major bleeding event within the past 30 days or assessed as high bleeding risk by the investigator. 12. Inability or unwillingness to provide informed consent or to comply with study procedures.

Clinical Research Directory

Design and Rationale of the COLT Study

Summary

Key Details

Conditions

Interventions

Eligibility Criteria