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Design and Rationale of the COLT Study

NCT07432529 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 940

Last updated 2026-02-25

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Azienda Sanitaria Locale ASL 6, Livorno

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-06-01
Completion
2027-06-01

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07432529 on ClinicalTrials.gov