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Study on the use of colchicine to reduce inflammation after deep vein thrombosis
EU CTIS ID: 2025-521836-12-00
What this study is testing
To evaluate the safety and efficacy of low-dose colchicine 0.5 mg versus placebo once daily in reducing the risk of Post-thrombotic syndrome (PTS) in patients with proximal lower-extremity deep vein thrombosis (DVT).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 18 years of age or older
- First, acute, symptomatic proximal (popliteal or more proximal vein) objectively-confirmed DVT of the lower extremity
- Written informed consent
You likely can't join if
- Any contraindication to colchicine as per summary of product characteristics (SmPC)
- Known active cancer
- Any of the following as measured within the past 1-3 months or at screening: alanine or aspartate aminotransferase >3x upper limit of normal (ULN); total bilirubin >2x ULN; creatinine clearance, calculated using Cockcroft-Gault formula, <30 mL/min
- Presence of HIV infection
- Hypersensitivity to the active substance or to any of the excipients
- Participation in another interventional trial within the past 30 days or 5 half-lives of the study drug, whichever is longer
See the full eligibility criteria
- 18 years of age or older
- First, acute, symptomatic proximal (popliteal or more proximal vein) objectively-confirmed DVT of the lower extremity
- Written informed consent
- Any contraindication to colchicine as per summary of product characteristics (SmPC)
- Known active cancer
- Any of the following as measured within the past 1-3 months or at screening: alanine or aspartate aminotransferase >3x upper limit of normal (ULN); total bilirubin >2x ULN; creatinine clearance, calculated using Cockcroft-Gault formula, <30 mL/min
- Presence of HIV infection
- Hypersensitivity to the active substance or to any of the excipients
- Participation in another interventional trial within the past 30 days or 5 half-lives of the study drug, whichever is longer
- Unwilling to provide consent
- Pregnancy, breastfeeding or may be considering pregnancy during the study period or women of childbearing potential unwilling to use appropriate contraception during sex
- Use of medications with known significant drug-to-drug interactions with colchicine including but not limited to erythromycin or clarithromycin
- History of an allergic reaction or significant sensitivity to colchicine
- Requirement of colchicine for other indications
- Active or chronic diarrhoea, or documented inflammatory bowel disease (i.e., Crohn’s disease or ulcerative colitis), collagenous colitis/irritable bowel syndrome, or existing blood dyscrasias
- Known or suspected, recent (<30 days) or active infections (acute or chronic)
- History of cirrhosis, chronic active hepatitis, or severe liver disease
- Recent (<30 days) or chronic use of systemic (oral, intravenous) immunosuppressive drugs (including but not limited to steroids, tumor necrosis factor-alpha blockers, cyclosporine)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.