Old drug, new hope: colchicine may stop Post-Clot leg damage
NCT ID NCT07432529
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding colchicine, an anti-inflammatory pill, to standard blood thinners can prevent long-term vein damage after a deep vein thrombosis (DVT) in the leg. About 940 adults with a first acute DVT will receive either colchicine or a placebo for six months and be followed for one year. The goal is to see if colchicine reduces the risk of post-thrombotic syndrome—a condition causing pain, swelling, and skin changes—and prevents new clots.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Colchicine (an anti-inflammatory drug) taken as a low-dose tablet
- What this could lead to
- If it works, this could offer a simple, low-cost way to reduce long-term leg pain and swelling after a blood clot.
- What could go wrong
- This is a large Phase 3 trial, but colchicine may not reduce complications and could cause side effects like stomach upset. Results are not yet available.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 940 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥18 years at the time of screening. 2. Objectively confirmed first, symptomatic acute proximal lower-limb deep vein thrombosis (DVT), involving the popliteal vein or more proximal veins, diagnosed within the previous 48 hours. 3. Planned initiation of standard anticoagulation therapy, including: * Low-molecular-weight heparin (LMWH) bridging to vitamin K antagonists (VKA) or direct oral anticoagulants (DOACs), * DOAC monotherapy according to local guidelines, * Fondaparinux or other guideline-recommended regimens. Note: Standard anticoagulation regimens include dose reduction of apixaban or rivaroxaban at the sixth month, as per local practice. 4. Ability and willingness to provide written informed consent and comply with all study procedures. Exclusion Criteria: Participants meeting any of the following criteria will be excluded: 1. History of prior DVT in the same limb. 2. Known contraindications to anticoagulation or anticipated inability to comply with study procedures. 3. Current use of colchicine or clinical indication requiring colchicine therapy. 4. Known hypersensitivity or allergy to colchicine. 5. Severe hepatic impairment, defined as ALT or AST \>3× upper limit of normal, or severe renal impairment (creatinine clearance \<30 mL/min). 6. Active malignancy with an estimated life expectancy \<12 months. 7. History of active or chronic gastrointestinal disease that may interfere with colchicine tolerance, including: 1. Inflammatory bowel disease (Crohn's disease or ulcerative colitis), 2. Collagenous colitis, 3. Irritable bowel syndrome, 4. Chronic or recurrent diarrhea. 8. Recent (\<30 days) or ongoing use of systemic immunosuppressive therapy, including but not limited to corticosteroids, cyclosporine, or tumor necrosis factor-alpha inhibitors. 9. Pregnancy or breastfeeding, or unwillingness to use effective contraception during the study period. 10. Concomitant use of strong CYP3A4 inhibitors or P-glycoprotein inhibitors contraindicated with colchicine. 11. Major bleeding event within the past 30 days or assessed as high bleeding risk by the investigator. 12. Inability or unwillingness to provide informed consent or to comply with study procedures.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New clot-sucking device tested in real-world vein clot treatment