Study on the use of colchicine to reduce inflammation after deep vein thrombosis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universita' Degli Studi G. D'Annunzio Di Chieti

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Hemic and Lymphatic Diseases [C15]

Decision date (initial)

2026-04-23

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Dipartimento di Medicina e Scienze dell’Invecchiamento Università degli Studi “G. d’Annunzio” Chieti

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

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).

Secondary objectives 11

1. To assess the efficacy of low-dose colchicine 0.5 mg in reducing the risk of PTS at 6 months
2. To assess PTS severity at 6 and 12 months according to clinical categories (mild, moderate, severe).
3. To evaluate changes in the Villalta score as a continuous variable at 6 and 12 months.
4. To evaluate the incidence of venous thromboembolism recurrence.
5. To evaluate the incidence of Arterial thromboembolism
6. To evaluate the incidence of the composite of adverse vascular events
7. To assess the incidence of major bleeding
8. To assess the incidence of clinically relevant non-major bleeding
9. To assess overall mortality during follow-up
10. To assess changes in patient-reported outcomes from baseline to 6 and 12 months, including functioning, symptoms, and quality of life, using specific and generic validated scales.
11. Safety objectives: to assess the safety of low-dose colchicine with particular attention to gastrointestinal symptoms, muscle pain, infections, renal failure, neutropenia, and neuropathy

Conditions and MedDRA coding

deep vein thrombosis

Study design 2 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. 18 years of age or older
2. First, acute, symptomatic proximal (popliteal or more proximal vein) objectively-confirmed DVT of the lower extremity
3. Written informed consent

Exclusion criteria 15

1. Any contraindication to colchicine as per summary of product characteristics (SmPC)
2. Pregnancy, breastfeeding or may be considering pregnancy during the study period or women of childbearing potential unwilling to use appropriate contraception during sex
3. Use of medications with known significant drug-to-drug interactions with colchicine including but not limited to erythromycin or clarithromycin
4. History of an allergic reaction or significant sensitivity to colchicine
5. Requirement of colchicine for other indications
6. 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
7. Known or suspected, recent (<30 days) or active infections (acute or chronic)
8. History of cirrhosis, chronic active hepatitis, or severe liver disease
9. Recent (<30 days) or chronic use of systemic (oral, intravenous) immunosuppressive drugs (including but not limited to steroids, tumor necrosis factor-alpha blockers, cyclosporine)
10. Known active cancer
11. 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
12. Presence of HIV infection
13. Hypersensitivity to the active substance or to any of the excipients
14. Participation in another interventional trial within the past 30 days or 5 half-lives of the study drug, whichever is longer
15. Unwilling to provide consent

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. PTS (Villalta score ≥5) at 12 months

Secondary endpoints 11

1. Proportion of patients with PTS (Villalta score ≥5) at 6 months
2. Proportion of patients according to the following PTS severity categories based on Villalta score category: mild (Villalta Score 5-9), moderate (Villalta score 10-14), severe (Villalta score ≥15 or presence of ulcer) at 6 and 12 months
3. Mean Villalta score and mean change from baseline (based on continuous Villalta score) at 6 and 12 months to estimate the severity of PTS
4. Incidence rate of recurrent venous thromboembolism (VTE) during follow-up (up to 12 months)
5. Incidence rate of arterial thromboembolism (ATE) during follow-up (up to 12 months)
6. Incidence rate of composite of adverse vascular events (comprising PTS, recurrent VTE, ATE) during follow-up (up to 12 months)
7. Incidence rate of major bleeding (as per International Society of Thrombosis and Haemostasis (ISTH) definition) during follow-up (up to 12 months)
8. Incidence rate of clinically relevant non-major bleeding (as per ISTH definition) during follow-up (up to 12 months)
9. All-cause mortality rate
10. Mean changes in patient-reported outcome measures (PROMs) from baseline to 6 and 12 months as assessed by functional scales (Patient reported Villalta-scale - PRV, Post-venous thromboembolism functional status - PVFS), and generic health-related and disease specific QOL questionnaires (EuroQoL-EQ-5D-5L, VEINES QOL/Sym, PEmb-QoL)
11. Safety endpoints: 1.Number and incidence rate of gastrointestinal adverse events that result in study drug discontinuation 2.Number and incidence rate of muscle pain episodes that results in study drug discontinuation 3.Number and incidence rate of infections episodes leading to hospitalization. Other: renal insufficiency; neutropenia and/or neuropathy leading to study drug discontinuatio

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universita' Degli Studi G. D'Annunzio Di Chieti

Sponsor organisation

Universita' Degli Studi G. D'Annunzio Di Chieti

Address

Via Dei Vestini 31

City

Chieti

Postcode

66100

Country

Italy

Scientific contact point

Organisation

Universita' Degli Studi G. D'Annunzio Di Chieti

Contact name

Di Nisio

Public contact point

Organisation

Universita' Degli Studi G. D'Annunzio Di Chieti

Contact name

Di Nisio

Third parties 1

Locations

1 EU/EEA country · 6 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications