Colchicine for Deep vein thrombosis

Inclusion criteria

• {"criterion_text":"- 18 years of age or older\n- First, acute, symptomatic proximal (popliteal or more proximal vein) objectively-confirmed DVT of the lower extremity\n- Written informed consent"}

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"- PTS (Villalta score ≥5) at 12 months","definition_or_measurement_approach":"Post-thrombotic syndrome defined as Villalta score ≥5 assessed at 12 months using the Villalta score."}

Secondary endpoints

• {"endpoint_text":"- Proportion of patients with PTS (Villalta score ≥5) at 6 months","definition_or_measurement_approach":"Proportion of patients meeting Villalta score ≥5 at 6 months."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Categorisation by Villalta score: mild 5-9; moderate 10-14; severe ≥15 or presence of ulcer; assessed at 6 and 12 months."}
• {"endpoint_text":"- Mean Villalta score and mean change from baseline (based on continuous Villalta score) at 6 and 12 months to estimate the severity of PTS","definition_or_measurement_approach":"Mean Villalta score and mean change from baseline, treated as continuous variable, measured at 6 and 12 months."}
• {"endpoint_text":"- Incidence rate of recurrent venous thromboembolism (VTE) during follow-up (up to 12 months)","definition_or_measurement_approach":"Incidence rate of recurrent VTE events occurring during follow-up up to 12 months."}
• {"endpoint_text":"- Incidence rate of arterial thromboembolism (ATE) during follow-up (up to 12 months)","definition_or_measurement_approach":"Incidence rate of arterial thromboembolism events during follow-up up to 12 months."}
• {"endpoint_text":"- Incidence rate of composite of adverse vascular events (comprising PTS, recurrent VTE, ATE) during follow-up (up to 12 months)","definition_or_measurement_approach":"Incidence rate of the composite outcome (PTS, recurrent VTE, ATE) during follow-up up to 12 months."}
• {"endpoint_text":"- Incidence rate of major bleeding (as per International Society of Thrombosis and Haemostasis (ISTH) definition) during follow-up (up to 12 months)","definition_or_measurement_approach":"Incidence rate of major bleeding defined according to ISTH criteria during follow-up up to 12 months."}
• {"endpoint_text":"- Incidence rate of clinically relevant non-major bleeding (as per ISTH definition) during follow-up (up to 12 months)","definition_or_measurement_approach":"Incidence rate of clinically relevant non-major bleeding defined per ISTH during follow-up up to 12 months."}
• {"endpoint_text":"- All-cause mortality rate","definition_or_measurement_approach":"Rate of death from any cause during follow-up."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Mean change from baseline in specified PROMs (PRV, PVFS, EQ-5D-5L, VEINES QOL/Sym, PEmb-QoL) at 6 and 12 months."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Safety endpoints include counts and incidence rates of specified adverse events (GI events, muscle pain leading to discontinuation, infections leading to hospitalization; renal insufficiency, neutropenia, neuropathy leading to discontinuation) during follow-up."}

Italy

Earliest CTIS Part Ii Submission Date

10-04-2026

Latest Decision Or Authorization Date

23-04-2026

Processing Time Days

13

Number Of Sites

6

Number Of Participants

122

Primary sponsor

Full Name

Universita' Degli Studi G. D'Annunzio Di Chieti

Organisation Type

Educational Institution

Country Of Registered Address

Italy

Third parties

• {"country":"Italy","full_name":"Center For Outcomes Research And Clinical Epidemiology S.r.l.","duties_or_roles":"Codes: 1,10,12,6,7","organisation_type":"Pharmaceutical company"}