Colchicine to Quench the Inflammatory Response After Deep Vein Thrombosis (The Conquer-DVT Pilot Trial)

Last updated: July 9, 2025
Sponsor: Ottawa Hospital Research Institute
Overall Status: Active - Recruiting

Phase

3

Condition

Thrombosis

Venous Thromboembolism

Vascular Diseases

Treatment

Colchicine 0.5 mg po

Placebo 0.5 mg po

Clinical Study ID

NCT06440694
CONQUER-DVT Pilot
  • Ages > 18
  • All Genders

Study Summary

This trial seeks to assess the feasibility of a full-scale, double-blind, placebo-controlled, randomized trial assessing whether low-dose colchicine (0.5 mg daily) reduces the risk of post-thrombotic syndrome (PTS) in patients with proximal lower extremity deep vein thrombosis (DVT).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Consenting patients 18 years of age or older with a first, acute, symptomaticproximal (popliteal vein or more proximal) objectively confirmed DVT of the lowerextremity will be eligible to participate in the study.

Exclusion

Exclusion Criteria:

  1. History of an allergic reaction or significant sensitivity to colchicine.

  2. Requirement of colchicine for other indications.

  3. Active or chronic diarrhea, or documented inflammatory bowel disease (i.e., Crohn'sdisease or ulcerative colitis), collagenous colitis or irritable bowel syndrome orexisting blood dyscrasias.

  4. Known or suspected, recent (<30 days) or active infections (acute or chronic).

  5. History of cirrhosis, chronic active hepatitis, or severe liver disease.

  6. Recent (<30 days) or chronic use of systemic (oral, intravenous) immunosuppressivedrugs (including but not limited to steroids, tumor necrosis factor-alpha blockers,cyclosporine).

  7. Known active cancer.

  8. Any of the following as measured within the past 1-3 months or at screening:alanine, or aspartate aminotransferase >3 times the upper limit of normal, totalbilirubin >2 times the upper limit of normal and a creatinine clearance byCockcroft-Gault formula <30 mL/min.

  9. Pregnancy, breast feeding or may be considering pregnancy during the study period orwomen of childbearing potential unwilling to use appropriate contraception duringsex;

  10. The use of medication with known drug-to-drug interactions (including but notlimited to erythromycin or clarithromycin).

  11. Unable or unwilling to provide consent.

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Colchicine 0.5 mg po
Phase: 3
Study Start date:
July 07, 2025
Estimated Completion Date:
December 01, 2027

Study Description

Eligible and consenting patients will be randomized via a central web-based randomization system (1:1 ratio) to receive one tablet of colchicine 0.5 mg or identical matching placebo daily starting within 7 days of initiation of anticoagulation for acute, symptomatic, proximal lower extremity Deep Vein Thrombosis (DVT) for a treatment course of 180 days (+/- 7 days). Study drug will start within 24 hours of randomization. The type, dose, and duration of anticoagulant therapy : unfractionated heparin, Low Molecular Weight Heparin (LMWH), fondaparinux, Direct Oral Anticoagulation (DOAC) or Vitamin K Agonist (VKA) will be left to the discretion of the treating physician or local investigator. The study drug will be continued until the end of the treatment period (180 days +/- 7 days). All patients will be observed until the end of study follow-up (365 days +/- 7 days).

Connect with a study center

  • The Ottawa Hospital General Campus

    Ottawa, Ontario K1H 8L6
    Canada

    Active - Recruiting

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