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NCT07432529: COLT
Design and Rationale of the COLT Study
Phase 3 trial testing Colchicine 0.5 MG Oral Tablet in Venous Thrombosis Deep (Limbs) in 940 participants. Not yet recruiting.
1 June 2027
Quick facts
| Lead sponsor | Azienda Sanitaria Locale ASL 6, Livorno |
|---|---|
| Phase | Phase 3 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 940 |
| Start date | 1 June 2026 |
| Primary completion | 1 June 2027 |
| Estimated completion | 1 June 2027 |
Drugs / interventions tested
- Colchicine 0.5 MG Oral Tablet
- Placebo
Conditions studied
- Venous Thrombosis Deep (Limbs) — all drugs for Venous Thrombosis Deep (Limbs) →
- Post-thrombotic Syndrome — all drugs for Post-thrombotic Syndrome →
- Venous Thromboembolism (VTE) — all drugs for Venous Thromboembolism (VTE) →
- Venous Insufficiency — all drugs for Venous Insufficiency →
Sponsor
Azienda Sanitaria Locale ASL 6, Livorno
Who can join
18 and older, any sex, with Venous Thrombosis Deep (Limbs) or Post-thrombotic Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Deep vein thrombosis (DVT) is a condition in which a blood clot forms in the deep veins of the leg and can lead to long-term problems such as leg pain, swelling, and reduced quality of life. Standard treatment with blood-thinning medication lowers the risk of complications, but some patients still develop long-term damage to the veins. Inflammation is thought to play an important role in these complications. This study will evaluate whether adding colchicine, an anti-inflammatory medication already used for other conditions, to standard anticoagulant therapy can improve outcomes in patients with acute DVT. Participants will be randomly assigned to receive either colchicine or a placebo, in addition to usual blood-thinning treatment, and will be followed for one year. The main goal of the study is to determine whether colchicine reduces the risk of developing long-term vein problems after DVT. The study will also assess the risk of new blood clots, vein recovery, quality of life, and the safety of colchicine treatment.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07432529
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07432529 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Azienda Sanitaria Locale ASL 6, Livorno
- Last refreshed: 25 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07432529.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing