Colchicine to reduce inflammation after proximal deep vein thrombosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a double‑blind, randomized (1:1), placebo‑controlled pilot trial testing colchicine 0.5 mg daily started within seven days of initiating anticoagulation for acute, symptomatic proximal lower‑extremity DVT. Participants receive study drug for 180 days (+/‑ 7 days) with clinical follow‑up continued to 365 days (+/‑ 7 days); anticoagulant type and dosing are determined by the treating clinician. Randomization is central and web‑based and study drug begins within 24 hours of randomization. The pilot is designed to test feasibility and gather preliminary data to inform a potential full‑scale Phase 3 trial.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Ottawa Hospital General Campus
  Ottawa, Ontario, Canada Recruiting
• Windsor Regional Hospital
  Windsor, Ontario, Canada Recruiting
• Centre de recherche du Centre hospitalier de l'Université de Montréal
  Montreal, Quebec, Canada Recruiting
• The Sir Mortimer B. Davis Jewish General Hospital
  Montreal, Quebec, Canada Not yet recruiting

Study contacts

• Principal investigator: Marc Carrier, MD,MSc,FRCPC — Ottawa Hospital Research Institute / Division of Hematology- The Ottawa Hospital
• Study coordinator: Marc Carrier, MD,MSc,FRCPC
• Email: mcarrier@toh.ca
• Phone: 6137378899

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• DoACs vs LMWH for blood flow after knee replacement

  This study tests whether rivaroxaban, apixaban, or LMWH work differently to support blood flow in the legs after total knee replacement in adults.

  Recruiting Military Hospital of Tunis · Tunis, Tunis Governorate · NCT07869615

• Prognostic value of the 2026 AHA/ACC PE classification in ED patients with acute PE

  This study tests whether the 2026 AHA/ACC five-category PE classification helps predict 30-day major adverse pulmonary embolism events in adults with acute PE presenting to the ED.

  Recruiting Marmara University Pendik Training and Research Hospital · Istanbul · NCT07805616

• Screening for blood clots in adults with acute heart failure

  This trial tests whether a guideline-based screening approach can detect pulmonary embolism in adults admitted with acute heart failure.

  Recruiting University Hospital, Angers · Agen and 9 other locations · NCT07499661

• Blood test and software to guide treatment for venous thromboembolism

  This project tests whether a blood-based ctDNA test combined with a software risk score can predict if VTE will come back in adults with cancer-associated DVT or PE who have finished 3–12 months of anticoagulation.

  Recruiting at 7 sites Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 7 other locations · NCT07399977

• Aspiration thrombectomy with the Symphony or Prodigy devices

  This project will try the Symphony and Prodigy aspiration thrombectomy devices to remove arterial, venous, or pulmonary blood clots in adults.

  Recruiting at 13 sites Imperative Care, Inc. · Huntsville, Alabama and 12 other locations · NCT07350499

• Combining European cohort data to find biomarkers that guide treatment for venous thromboembolism

  This project combines clinical, biological and imaging data from European patient cohorts to try to find biomarkers that predict clot recurrence, bleeding, or death in people with venous thromboembolism.

  Recruiting University Hospital, Brest · Brest · NCT07328152

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.