Actively Recruiting
Colchicine to Quench the Inflammatory Response After Deep Vein Thrombosis: A Randomized Controlled Pilot Trial
Led by Ottawa Hospital Research Institute · Updated on 2025-12-30
150
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether a low dose of colchicine (0.5 mg daily) can reduce the risk of post-thrombotic syndrome (PTS) in patients with a recent proximal lower extremity deep vein thrombosis (DVT). This pilot trial is designed as a double-blind, placebo-controlled, randomized study to assess the feasibility of a larger trial and to better understand colchicine's potential role in reducing inflammation after DVT. Participants will be randomly assigned to receive either colchicine 0.5 mg or a matching placebo tablet once daily for 180 days, starting within 7 days of beginning anticoagulant treatment for their DVT. The choice and duration of anticoagulation therapy will be determined by each patient's physician. After the treatment period, study drugs will be stopped, and patients will be followed for a total of one year to monitor outcomes. During the study, participants will undergo regular assessments to evaluate recruitment, consent, retention, and adherence rates. Researchers will measure the occurrence and severity of post-thrombotic syndrome at 180 and 365 days, using tools such as the VILLALTA scale and quality of life assessments. Safety will be monitored by tracking bleeding events and overall mortality. The study aims to gather data on both clinical outcomes and cost-effectiveness of colchicine treatment.
CONDITIONS
Brief Title
Colchicine to Quench the Inflammatory Response After Deep Vein Thrombosis (The Conquer-DVT Pilot Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Consenting patients 18 years of age or older
- First, acute, symptomatic proximal deep vein thrombosis (popliteal vein or higher) confirmed by objective testing
- Lower extremity deep vein thrombosis
You will not qualify if you...
- History of allergic reaction or significant sensitivity to colchicine
- Need for colchicine for other medical reasons
- Active or chronic diarrhea or inflammatory bowel disease including Crohn's disease, ulcerative colitis, collagenous colitis, or irritable bowel syndrome
- Known or suspected recent (less than 30 days) or active infections
- History of cirrhosis, chronic active hepatitis, or severe liver disease
- Recent (less than 30 days) or chronic use of systemic immunosuppressive drugs such as steroids or tumor necrosis factor-alpha blockers
- Known active cancer
- Liver enzyme levels (alanine or aspartate aminotransferase) more than 3 times the upper limit of normal, total bilirubin more than 2 times the upper limit of normal, or creatinine clearance less than 30 mL/min within past 1-3 months or at screening
- Pregnancy, breastfeeding, or women of childbearing potential unwilling to use contraception during the study
- Use of medications with known interactions such as erythromycin or clarithromycin
- Unable or unwilling to provide consent
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 180 days (+/- 7 days)
Participants receive one tablet of colchicine 0.5 mg or placebo daily starting within 7 days of anticoagulation initiation for acute, symptomatic, proximal lower extremity Deep Vein Thrombosis.
Visits occur for study drug administration and monitoring during the 180-day treatment period
Duration - Up to 365 days (+/- 7 days) from treatment start
Participants are observed until the end of study follow-up to assess long-term outcomes after treatment ends.
Periodic visits for assessments up to 365 days
Trial Site Locations
Total: 3 locations
1
The Ottawa Hospital General Campus
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
2
Centre de recherche du Centre hospitalier de l'Université de Montréal
Montreal, Quebec, Canada, H2X 0A9
Actively Recruiting
3
The Sir Mortimer B. Davis Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Not Yet Recruiting
Research Team
M
Marc Carrier, MD,MSc,FRCPC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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