Recruiting
Phase 3

Colchicine

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT06440694

Conditions

Venous Thromboembolism

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Colchicine 0.5 mg po

Placebo 0.5 mg po

Study Details

Brief 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).

Conditions

Venous Thromboembolism

Study ID

NCT06440694

Start date

Jul 7, 2025

Status verified date

Jul, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

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's disease or ulcerative colitis), collagenous colitis or irritable bowel syndrome or existing 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) immunosuppressive drugs (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, total bilirubin >2 times the upper limit of normal and a creatinine clearance by Cockcroft-Gault formula <30 mL/min.
9. Pregnancy, breast feeding or may be considering pregnancy during the study period or women of childbearing potential unwilling to use appropriate contraception during sex;
10. The use of medication with known drug-to-drug interactions (including but not limited to erythromycin or clarithromycin).
11. Unable or unwilling to provide consent.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental Arm: Colchicine

Colchicine 0.5 mg po once daily for 180 days. After the Day - 180 follow up, the study treatment will be discontinued and subsequent treatment will be at the discretion of the attending physician.

placebo comparator: Control Arm : Placebo

Placebo 0.5 mg po once daily for 180 days. After the Day - 180 follow up, the study treatment will be discontinued and subsequent treatment will be at the discretion of the attending physician.

Interventions

Colchicine 0.5 mg po

Colchicine 0.5 mg po once daily for 180 days.

Placebo 0.5 mg po

Placebo 0.5 mg po once daily for 180 days.

Primary outcome measure

  • Pilot Trial Primary Outcome: Recruitment Rate [ Time Frame: 12 months ]
  • Full-Scale Trial Primary Outcome: Post Thrombotic Syndrome [ Time Frame: 180 days ]

Central Contacts and Locations

Central contacts

Marc Carrier, MD,MSc,FRCPC

6137378899mcarrier@toh.ca

Locations

The Ottawa Hospital General Campus

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Principal Investigator:

Marc Carrier, MD,MSc,FRCPC

Windsor Regional Hospital

Recruiting

Windsor, Ontario, Canada, N8W2X3

Contacts

Principal Investigator:

Andrea Cervi, MD, MSc, FRCPC,

Centre de recherche du Centre hospitalier de l'Université de Montréal

Recruiting

Montreal, Quebec, Canada, H2X 0A9

Contacts

Principal Investigator:

Emmanuelle Duceppe, MD,PhD,FRCPC

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Keywords

  • Proximal Lower Extremity Deep Vein Thrombosis
  • Randomized Trial
  • Colchicine
  • Post Thrombotic Syndrome
  • Inflammation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2026-07-23.