Clinical trial • Phase III • Cardiology
Colchicine for Peripheral arterial disease | Intermittent claudication
Phase III trial of Colchicine for Peripheral arterial disease | Intermittent claudication.
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Peripheral arterial disease | Intermittent claudication
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 25-10-2024
- First CTIS Authorization Date
- 26-02-2025
Trial design
Randomised, active arm: colchicine 0.5 mg daily; control arm: placebo matching tiofarma colchicine 500 mcg tablets, daily Phase III trial across 19 sites in Belgium, Italy, Netherlands and others.
- Randomised
- Yes
- Comparator
- Active arm: Colchicine 0.5 mg daily; Control arm: Placebo matching Tiofarma colchicine 500 mcg tablets, daily
- Target Sample Size
- 5852
Eligibility
Recruits 5852 Vulnerable population not selected; written informed consent from the patient is required. No assent or guardian consent provisions are specified in the available documentation..
- Pregnancy Exclusion
- Woman who is pregnant, or breast-feeding or of child-bearing potential not protected by reliable contraception or is planning conception during the study
- Vulnerable Population
- Vulnerable population not selected; written informed consent from the patient is required. No assent or guardian consent provisions are specified in the available documentation.
Inclusion criteria
- {"criterion_text":"- Age > 18 years"}
- {"criterion_text":"- Symptomatic atherosclerotic LE PAD fulfilling at least one of the following: a. Intermittent claudication with ankle/arm blood pressure ratio* (ABI ≤ 0.90) or artery stenosis ≥ 50% plus one of i. >1 vascular bed affected by atherosclerosis ii. Diabetes iii. Heart failure iv. Chronic kidney disease (eGFR < 60 mL/min/1.73 m2); b. Rest pain (mostly in foot) OR necrosis of limb OR gangrene of limb (corresponding to either Fontaine stages 3 or 4 OR Rutherford Classification categories 4 to 6). All must have an ankle/arm blood pressure ratio* (ABI ≤ 0.90) OR artery stenosis ≥ 50%. * In cases of incompressible ankle arteries, the presence of toe pressure ≤ 60 mm Hg or toe-brachial index ≤ 0.70 is acceptable; c. Revascularization defined as limb bypass surgery or endovascular revascularization procedures (irrespective of the specific device used), including percutaneous transluminal angioplasty/stent of iliac or infra-inguinal arteries or extra-anatomical bypass surgery; or d. Leg or foot amputation for arterial vascular indications"}
- {"criterion_text":"- Written informed consent from the patient"}
Exclusion criteria
- {"criterion_text":"- Contraindication to colchicine (including hypersensitivity to the active substance or to any of the excipients)"}
- {"criterion_text":"- Long term requirement for colchicine for another clinical indication"}
- {"criterion_text":"- Active diarrhoea"}
- {"criterion_text":"- eGFR < 30 mL/min/1.73 m2"}
- {"criterion_text":"- Cirrhosis or severe chronic liver disease"}
- {"criterion_text":"- Woman who is pregnant, or breast-feeding or of child-bearing potential not protected by reliable contraception or is planning conception during the study"}
- {"criterion_text":"- Current or planned long term use of cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics (with the exception of azithromycin)"}
- {"criterion_text":"- Patients who are deemed unlikely to return for follow-up"}
- {"criterion_text":"- Patients with life expectancy < 1 year"}
- {"criterion_text":"- Patients with blood dyscrasias"}
- {"criterion_text":"- Patients with severe heart failure (NYHA class IV)"}
- {"criterion_text":"- Patients with severe gastrointestinal insufficiency"}
- {"criterion_text":"- Participation in a clinical trial in which an investigational drug was administered within 30 days of screening, or within the 5 half-lives of the study drug, whichever is longer"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Rate of major adverse cardiovascular and limb events (MACE or MALE). This composite outcome consists of cardiovascular deaths, myocardial infarction, stroke, and severe limb ischemia that requires a vascular intervention (i.e., pharmacological reperfusion, endovascular or surgical revascularization) or a major vascular amputation (defined as ankle/transtibial amputation or higher).","definition_or_measurement_approach":"Composite endpoint defined as cardiovascular deaths, myocardial infarction, stroke, and severe limb ischemia requiring vascular intervention or major vascular amputation (ankle/transtibial amputation or higher). Measurement approach not further specified in the provided extract."}
Secondary endpoints
- {"endpoint_text":"- Extended MALE; This composite outcome includes major adverse limb events (MALE) as well as revascularization for new or worsening claudication of new stenosis or occlusion detected on screening after a previous intervention","definition_or_measurement_approach":"Composite endpoint including MALE plus revascularization for new/worsening claudication or new stenosis/occlusion detected on screening after prior intervention."}
- {"endpoint_text":"- Cardiovascular death","definition_or_measurement_approach":""}
- {"endpoint_text":"- Myocardial infarction","definition_or_measurement_approach":""}
- {"endpoint_text":"- Stroke","definition_or_measurement_approach":""}
- {"endpoint_text":"- Hospitalization","definition_or_measurement_approach":""}
- {"endpoint_text":"- Acute or chronic limb-threatening ischemia","definition_or_measurement_approach":""}
- {"endpoint_text":"- All revascularization (coronary or cerebrovascular or lower limb or other peripheral revascularization)","definition_or_measurement_approach":"Includes coronary, cerebrovascular, lower limb or other peripheral revascularization procedures."}
- {"endpoint_text":"- Total vascular amputation","definition_or_measurement_approach":""}
- {"endpoint_text":"- Overall mortality","definition_or_measurement_approach":""}
- {"endpoint_text":"- Any thrombosis or thromboembolism (arterial and venous)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Fontaine Stage","definition_or_measurement_approach":""}
- {"endpoint_text":"- Standard Assessment of Global Everyday Activities (SAGEA)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Vascular Quality of Life Questionnaire-6 (VascQOL-6)","definition_or_measurement_approach":""}
- {"endpoint_text":"- EuroQol 5 Dimension 5 Level (EQ-5D-5L)","definition_or_measurement_approach":""}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 5852
- Recruitment Window Months
- 60
- Consent Approach
- Written informed consent from the patient is required. Subject information and informed consent forms are available in country-specific versions: Belgium (DE, NL, FR), Italy (IT), Netherlands (NL), Germany (DE). No paediatric assent or guardian consent provisions are specified in the provided documentation.
Methods
- Site-based recruitment via participating hospitals/vascular surgery and cardiology clinics (documented in site-specific 'Recruitment and Informed Consent Procedures' K1 PDFs)
- Study website (document: K2_Recruitment Material_Study Website_NL) used for recruitment materials
- Letters to general practitioners (documents: L2_Letter to GP_IT and L2_Letter to GP_NL) documented as part of subject information/invitation materials
Geography
- Total Number Of Sites
- 19
- Total Number Of Participants
- 1898
Belgium
- Earliest CTIS Part Ii Submission Date
- 06-11-2024
- Latest Decision Or Authorization Date
- 27-02-2025
- Processing Time Days
- 113
- Number Of Sites
- 1
- Number Of Participants
- 48
Sites
- Site Name
- UZ Leuven
- Department Name
- Cardiology
- Contact Person Name
- Thomas Vanassche
- Contact Person Email
- thomas.vanassche@uzleuven.be
Italy
- Earliest CTIS Part Ii Submission Date
- 24-01-2025
- Latest Decision Or Authorization Date
- 01-07-2025
- Processing Time Days
- 158
- Number Of Sites
- 7
- Number Of Participants
- 250
Sites
- Site Name
- Universita' Degli Studi G. D'Annunzio Di Chieti
- Department Name
- Vascular Surgery
- Contact Person Name
- Marcello Di Nisio
- Contact Person Email
- mdinisio@unich.it
- Site Name
- Azienda Ulss 6 Euganea
- Department Name
- Internal Medicine-Thrombosis
- Contact Person Name
- Sofia Barbar
- Contact Person Email
- sofia.barbar@aulss6.veneto.it
- Site Name
- Azienda Unita' Locale Socio Sanitaria N. 2 Marca Trevigiana
- Department Name
- Cardiology
- Contact Person Name
- Beniamino Zalunardo
- Contact Person Email
- beniamino.zalunardo@aulss2.veneto.it
- Site Name
- Ospedale Ss. Giovanni E Paolo
- Department Name
- Cardiology
- Contact Person Name
- Cristiano Bortoluzzi
- Contact Person Email
- crisbort@libero.it
- Site Name
- Azienda Unita Locale Socio Sanitaria N. 1 Dolomiti
- Department Name
- Cardiology
- Contact Person Name
- Romeo Martini
- Contact Person Email
- romeo.martini@aulss1.veneto.it
- Site Name
- AULSS 5 POLESANA, PRESIDIO OSPEDALIERO DI ROVIGO
- Department Name
- Cardiology
- Contact Person Name
- Marco Marzolo
- Contact Person Email
- marco.marzolo@aulss5.veneto.it
- Site Name
- Azienda Ospedaliera di Padova
- Department Name
- Cardiology
- Contact Person Name
- Paolo Simioni
- Contact Person Email
- paolo.simioni@unipd.it
Netherlands
- Earliest CTIS Part Ii Submission Date
- 03-06-2025
- Latest Decision Or Authorization Date
- 26-11-2025
- Processing Time Days
- 176
- Number Of Sites
- 10
- Number Of Participants
- 1500
Sites
- Site Name
- Alrijne Zorggroep Stichting
- Department Name
- Vascular Surgery
- Contact Person Name
- Borger van der Burg
- Contact Person Email
- blsborgervanderburg@alrijne.nl
- Site Name
- Slingeland Ziekenhuis
- Department Name
- Vascular Surgery
- Contact Person Name
- D.M. Scharn
- Contact Person Email
- d.scharn@slingeland.nl
- Site Name
- Stichting Elisabeth-Tweesteden Ziekenhuis
- Department Name
- Vascular Surgery
- Contact Person Name
- M.K. Dinkelman
- Contact Person Email
- m.dinkelman@etz.nl
- Site Name
- Meander Medisch Centrum
- Department Name
- Vascular Surgery
- Contact Person Name
- Hidde Jongsma
- Contact Person Email
- h.jongsma@meandermc.nl
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- Vascular Surgery
- Contact Person Name
- Martin Teraa
- Contact Person Email
- M.Teraa@umcutrecht.nl
- Site Name
- Universitair Medisch Centrum Groningen
- Department Name
- Vascular Surgery
- Contact Person Name
- Ben Saleem
- Contact Person Email
- b.r.saleem@umcg.nl
- Site Name
- Academisch Ziekenhuis Maastricht
- Department Name
- Vascular Surgery
- Contact Person Name
- Barend Mees
- Contact Person Email
- barend.mees@mumc.nl
- Site Name
- Deventer Ziekenhuis
- Department Name
- Vascular Surgery
- Contact Person Name
- Bob van Tongeren
- Contact Person Email
- r.b.m.vantongeren@dz.nl
- Site Name
- Groene Hart Ziekenhuis
- Department Name
- Vascular Surgery
- Contact Person Name
- Joris Blok
- Contact Person Email
- Joris.Blok@ghz.nl
- Site Name
- Jeroen Bosch Ziekenhuis Stichting
- Department Name
- Vascular Surgery
- Contact Person Name
- Olivier Koning
- Contact Person Email
- a.v.asseldonk@jbz.nl
Germany
- Earliest CTIS Part Ii Submission Date
- 12-03-2026
- Latest Decision Or Authorization Date
- 24-03-2026
- Processing Time Days
- 12
- Number Of Sites
- 1
- Number Of Participants
- 100
Sites
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Cardiology and Angiology
- Contact Person Name
- Christos Rammos
- Contact Person Email
- christos.rammos@uk-essen.de
Sponsor
Primary sponsor
- Full Name
- Hamilton Health Sciences Corporation
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Canada
Investigational products
- Investigational Product Name
- Colchicine Tiofarma 500 microgram Tablets
- Active Substance
- Colchicine
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- oral
- Authorisation Status
- Marketing authorisation PL 17299/0003 (prodAuthStatus 2)
- Starting Dose
- 0.5 mg daily
- Dose Levels
- 0.5 mg
- Frequency
- daily
- Maximum Dose
- 0.5 mg
- Investigational Product Name
- Placebo matching Tiofarma colchicine 500 mcg tablets
- Modality
- Other
- Frequency
- daily
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