Colchicine for Prevention of Vascular Inflammation in Non-cardio Embolic Stroke
CONVINCE
CONVINCE - (COlchicine for preventioN of Vascular Inflammation in Non- CardioEmbolic Stroke) - a Randomised Clinical Trial of Low-dose Colchicine for Secondary Prevention After Stroke
1 other identifier
interventional
3,154
13 countries
144
Brief Summary
This study evaluates the use of Colchicine in adults over 40 years of age who have suffered an ischaemic stroke or transient ischaemic attack NOT caused by cardiac embolism or other defined causes. Patients will be randomised to 0.5 mg/day of Colchicine plus usual care, or to usual care alone. To investigate the efficacy of low dose colchicine (0.5mg/day) plus usual care (defined as antiplatelet, lipid-lowering, antihypertensive treatment, and appropriate lifestyle advice) compared with usual care alone to prevent non-fatal recurrent ischaemic stroke, myocardial infarction, cardiac arrest, hospitalization for unstable angina and vascular death after ischaemic stroke or transient ischaemic attack (TIA) not caused by cardiac embolism or other defined causes unrelated to atherosclerosis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2016
Longer than P75 for phase_3
144 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2016
CompletedFirst Posted
Study publicly available on registry
September 13, 2016
CompletedStudy Start
First participant enrolled
December 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2024
CompletedMarch 13, 2025
June 1, 2024
7.1 years
September 8, 2016
March 11, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Recurrence of non-fatal ischemic stroke
Any recurrence of non-fatal ischemic stroke
any time within 60 month
on-fatal Major Cardiac event
Non-fatal hospitalization for unstable angina, myocardial infarction, cardiac arrest
any time within 60 months
Vascular death
Fatal ischemic stroke, myocardial infarction, cardiac arrest
60 months
Study Arms (2)
Colchicine treatment
ACTIVE COMPARATORColchicine 0.5mg/day plus usual care for 60 months
Usual Standard of care alone
NO INTERVENTIONNormal standard of care remains for these patients
Interventions
Eligibility Criteria
You may qualify if:
- Written informed consent consistent with ICH-GCP guidelines and local laws signed prior to all trial-related procedures.
- Age 40 years or greater
- Either,
- ischaemic stroke without major disability (modified Rankin score 3 or less)
- or high-risk TIA
- Qualifying stroke/TIA probably caused by large artery stenosis, small artery occlusion (lacunar stroke), or cryptogenic embolism, with cardiac embolism or other defined stroke mechanism deemed unlikely in the opinion of the treating physician.
- GFRgreater than or equal to 50 ml/min.
- In the opinion of the treating physician, patient is medically-stable, capable of participating in a randomised trial, and willing to attend follow-up.
You may not qualify if:
- Cardio-embolic stroke/TIA, probably caused by identified atrial fibrillation (permanent or paroxysmal), in the opinion of the treating physician.
- Cardio-embolic stroke/TIA probably caused by other identified cardiac source (intra-cardiac thrombus, endocarditis, metallic heart valve, low ejection fraction \<30%), in the opinion of the treating physician.
- Stroke/TIA caused by dissection, endocarditis, paradoxical embolism, drug use, venous thrombosis, within 48 hours aftercarotid or cardiac surgery, hypercoagulability states, migraine, or inherited cerebrovascular disorders (eg. Fabry's disease, CADASIL), in the opinion of the treating physician.
- History of myopathy or myalgias with raised creatine kinase (CK) on statin therapy.
- Blood dyscrasia defined as anaemia (haemoglobin \<10g/dL), thrombocytopenia (platelet count \<150 x109/L) or leucopenia (white cell count \<4 x109/L) at randomisation.
- Impaired hepatic function (transaminases greater than twice upper limit of normal) at randomisation.
- Concurrent treatment with moderate or strong CYP3A4 inhibitors (clarithromycin, erythromycin, telithromycin, other macrolide antibiotics, ketoconazole, itraconazole, voriconazole, ritonavir, atazanavir, indinavir, other HIV protease inhibitors, verapamil, diltiazem, quinidine, digoxin, disulfiram) or P-gp inhibitors (cyclosporine) at randomisation.
- Symptomatic peripheral neuropathy and pre-existing progressive neuromuscular disease
- Inflammatory bowel disease (Crohn's or ulcerative colitis) or chronic diarrhoea.
- \. Dementia, sufficient to impair independence in basic activities of daily living.
- \. Active malignancy, known hepatitis B or C, or HIV infection prior to qualifying stroke/TIA.
- \. Impaired swallow preventing oral administration of study medication. 12. History of poor medication compliance. 13. Unlikely to comply with study procedures and follow-up visits due to severe or fatal comorbid illness or other factor (eg. inability to travel for follow up visits), in opinion of randomising physician.
- \. Pregnancy, breast-feeding, or pre-menopausal women 15. Patient concurrently participating in another clinical trial with an investigational drug or device, or use of investigational drug within 30 days or 5 half-lives before the Screening visit (whichever is longer) 16. Known allergy or sensitivity to colchicine.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University College Dublinlead
- Health Research Board, Irelandcollaborator
- Irish Heart Foundationcollaborator
- University of Limerickcollaborator
- University of Edinburghcollaborator
- National University of Ireland, Galway, Irelandcollaborator
- Universitat de Lleidacollaborator
- Universitaire Ziekenhuizen KU Leuvencollaborator
Study Sites (145)
Uza, Antwerpen
Antwerp, Belgium
AZ Sint Jan
Bruges, Belgium
AZ St. Lucas, BRUGGE
Bruges, Belgium
UCL, Brussels
Brussels, Belgium
UZ Brussel
Brussels, Belgium
UZ Gent
Ghent, Belgium
AZ Groeninge Kortrijk
Kortrijk, Belgium
UZ Leuven
Leuven, Belgium
CHC Liege
Liège, Belgium
AZ Damiaan, OOSTENDE
Ostend, Belgium
AZ Delta, ROESELARE
Roeselare, Belgium
Foothills Medical Centre, Calgary
Calgary, Canada
Kingston Hospital
Kingston, Canada
Vancouver General Hospital
Vancouver, Canada
St. Anne´s University Hospital
Brno, Czechia
Hospital Jihlava
Jihlava, Czechia
Bispebjerg Hospital
Bispebjerg, Denmark
Rigshospitalet Glostrup
Glostrup Municipality, Denmark
Herlev Hospital
Herlev, Denmark
Nordsjællands Hospital
Hillerød, Denmark
Tartu University Hospital
Tartu, Estonia
Rhön-Klinikum Campus Bad Neustadt
Bad Neustadt an der Saale, Germany
Vivantes Auguste-Viktoria Klinikum
Berlin, Germany
Vivantes Humboldt-Klinikum
Berlin, Germany
Vivantes Klinikum Neukölln, Berlin
Berlin, Germany
St. Josef-Hospital Klinikum der Ruhr-Universität Bochum
Bochum, Germany
Universitätsklinikum Bonn
Bonn, Germany
Krankenhaus Buchholz
Buchholz, Germany
Klinikum Dortmund gGmbH
Dortmund, Germany
Universitätsklinikum Essen
Essen, Germany
Frankfurt University Hospital
Frankfurt, Germany
Klinikum Fulda gAG, Universitätsmedizin Marburg-Campus Fulda
Fulda, Germany
SRH Wald-Klinikum Gera GmbH
Gera, Germany
Krakenhaus Martha Maria Halle Dolau
Halle, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Universitätsklinikum Heidelberg
Heidelberg, Germany
Universitätsklinikum Leipzig AöR
Leipzig, Germany
Klinikum Main-Spessart, Standort Krankenhaus Lohr
Lohr, Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck, Germany
Klinikum der Universität München
München, Germany
Mediclin-Fachklinik Rhein/Ruhr
Rheine, Germany
Medinos Kliniken des Landkreises Sonneberg
Sonneberg, Germany
Universitätsklinikum Würzburg
Würzburg, Germany
Cavan General Hospital
Cavan, Cavan, Ireland
Cork University Hospital
Cork, Ireland
Beaumont Hospital
Dublin, Ireland
Connolly Hospital, Blanchardstown
Dublin, Ireland
Mater Misericordiae University Hospital
Dublin, Ireland
St James's Hospital
Dublin, Ireland
St Vincent's University Hospital
Dublin, Ireland
Tallaght University Hospital
Dublin, Ireland
Galway University Hospital
Galway, Ireland
St Lukes General Hospital
Kilkenny, Ireland
University Hospital Limerick
Limerick, Ireland
Our Lady of Lourdes, Drogheda
Louth, Ireland
Sligo University Hospital
Sligo, Ireland
South Tipperary General Hospital, Clonmel
Tipperary, Ireland
University Hospital Waterford
Waterford, Ireland
Lithuanian University Hospital of Health Sciences Kaunos Klinikos
Kaunas, Lithuania
Vilnius University Hospital Santaros Clinics
Vilnius, Lithuania
Academic Medical Center
Amsterdam, Netherlands
Gelre Ziekenhuis Apeldoorn
Apeldoorn, Netherlands
Reinier de Graaf Hospital
Delft, Netherlands
Radboud University Medical Centre
Nijmegen, Netherlands
Hospital Nicholas Copernicus
Gdansk, Poland
Specialist Hospital of Saint Luke
Gmina Końskie, Poland
Medical University of Silesia Hospital No7
Rokietnica, Poland
Institute of Psychiatry and Neurology
Warsaw, Poland
Hospital de Santa Maria, Centro Hospitalar Lisboa Norte
Lisbon, Portugal
Hospital Egas Moniz
Lisbon, Portugal
Hospital Universitario de Sao Jao
Porto, Portugal
Complejo Hospitalario Universitario A Coruña
A Coruña, Spain
H. de Albacete
Albacete, Spain
Hospital de Sant Pau
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Hospital Moises Broggi. Comprehensive Health Consortium
Barcelona, Spain
H U. Josep Trueta, Girona
Girona, Spain
Hospital Universitari Arnau de Vilanova de Lleida
Lleida, Spain
H. U. Ramón y Cajal, Madrid
Madrid, Spain
Centro Medico de Asturias
Oviedo, Spain
H Parc Taulí de Sabadell
Sabadell, Spain
H U. Virgen del Rocío, Sevilla
Seville, Spain
Hospital Virgen Macarena Sevilla
Seville, Spain
H Joan XXIII, Tarragona
Tarragona, Spain
University Hospital Bern
Bern, Switzerland
Bronglais General Hospital
Aberystwyth, United Kingdom
Aintree University Hospital
Aintree, United Kingdom
Monklands Hospital
Airdrie, United Kingdom
Antrim Area Hospital
Antrim, United Kingdom
William Harvey Hospital
Ashford, United Kingdom
Royal Victoria Hospital
Belfast, United Kingdom
Royal Blackburn Hospital
Blackburn, United Kingdom
Pilgrim Hospital
Boston, United Kingdom
Royal Bournemouth Hospital
Bournemouth, United Kingdom
West Suffolk Hospital
Bury St Edmunds, United Kingdom
Addenbrookes Hospital
Cambridge, United Kingdom
Kent and Canterbury Hospital
Canterbury, United Kingdom
Countess of Chester Hospital
Chester, United Kingdom
Chesterfield Royal Hospital
Chesterfield, United Kingdom
St Richards Hospital
Chichester, United Kingdom
Craigavon Area Hospital
Craigavon, United Kingdom
Northumbria Specialist Emergency Care Hospital
Cramlington, United Kingdom
Croydon University Hospital
Croydon, United Kingdom
Royal Derby Hospital
Derby, United Kingdom
North Durham University Hospital
Durham, United Kingdom
South West Acute Hospital
Enniskillen, United Kingdom
Royal Devon & Exeter Hospital
Exeter, United Kingdom
Queen Elizabeth Hospital Gateshead
Gateshead, United Kingdom
Medway Maritime Hospital
Gillingham, United Kingdom
Hairmyres Hospital
Glasgow, United Kingdom
Queen Elizabeth University Hospital Glasgow
Glasgow, United Kingdom
Wycombe Hospital
High Wycombe, United Kingdom
Raigmore Hospital
Inverness, United Kingdom
Kingston Hospital
Kingston, United Kingdom
Leicester Royal Infirmary
Leicester, United Kingdom
University Hospital Lewisham
Lewisham, United Kingdom
Lincoln County Hospital
Lincoln, United Kingdom
Royal Liverpool University Hospital
Liverpool, United Kingdom
Charing Cross Hospital
London, United Kingdom
King's College Hospital
London, United Kingdom
Royal London Hospital
London, United Kingdom
St George's Hospital
London, United Kingdom
St Thomas' Hospital
London, United Kingdom
University College London Hospital
London, United Kingdom
Altnagelvin Area Hospital
Londonderry, United Kingdom
Luton & Dunstable University Hospital
Luton, United Kingdom
Queen Elizabeth the Queen Mother Hospital
Margate, United Kingdom
Norfolk and Norwich Hospital
Norwich, United Kingdom
Nottingham City Hospital
Nottingham, United Kingdom
Peterborough Hospital
Peterborough, United Kingdom
Derriford Hospital
Plymouth, United Kingdom
Royal Hallamshire Hospital
Sheffield, United Kingdom
Southend University Hospital
Southend, United Kingdom
Stepping Hill Hospital
Stockport, United Kingdom
Royal Stoke University Hospital
Stoke, United Kingdom
Sunderland Royal Hospital
Sunderland, United Kingdom
King's Mill Hospital
Sutton in Ashfield, United Kingdom
Great Western Hospital
Swindon, United Kingdom
Princess Royal Hospital
Telford, United Kingdom
Royal Cornwall Hospital
Truro, United Kingdom
Whiston Hospital
Whiston, United Kingdom
New Cross Hospital
Wolverhampton, United Kingdom
Worthing Hospital
Worthing, United Kingdom
Yeovil District Hospital
Yeovil, United Kingdom
Related Publications (4)
Kelly P, Lemmens R, Weimar C, Walsh C, Purroy F, Barber M, Collins R, Cronin S, Czlonkowska A, Desfontaines P, De Pauw A, Evans NR, Fischer U, Fonseca C, Forbes J, Hill MD, Jatuzis D, Korv J, Kraft P, Kruuse C, Lynch C, McCabe D, Mikulik R, Murphy S, Nederkoorn P, O'Donnell M, Sandercock P, Schroeder B, Shim G, Tobin K, Williams DJ, Price C. Long-term colchicine for the prevention of vascular recurrent events in non-cardioembolic stroke (CONVINCE): a randomised controlled trial. Lancet. 2024 Jul 13;404(10448):125-133. doi: 10.1016/S0140-6736(24)00968-1. Epub 2024 Jun 7.
PMID: 38857611BACKGROUNDMaes L, Walsh C, Weimar C, Purroy F, Price C, Clarke B, Castro P, Czlonkowska A, Cuadrado-Godia E, Fischer U, Fonseca AC, Hill MD, Jatuzis D, Korv J, Kruuse C, Mikulik R, Nederkoorn PJ, Sztriha L, Thieme M, Kelly P, Lemmens R. Effect of colchicine for secondary prevention according to stroke subtype: A secondary analysis of the CONVINCE randomized trial. Int J Stroke. 2025 Dec 2:17474930251406818. doi: 10.1177/17474930251406818. Online ahead of print.
PMID: 41328787DERIVEDAkl E, Sahami N, Labos C, Genest J, Zgheib A, Piazza N, Jolly S. Meta-Analysis of Randomized Trials: Efficacy and Safety of Colchicine for Secondary Prevention of Cardiovascular Disease. J Interv Cardiol. 2024 Mar 12;2024:8646351. doi: 10.1155/2024/8646351. eCollection 2024.
PMID: 38505729DERIVEDBouabdallaoui N, Tardif JC. Colchicine in the Management of Acute and Chronic Coronary Artery Disease. Curr Cardiol Rep. 2021 Jul 16;23(9):120. doi: 10.1007/s11886-021-01560-w.
PMID: 34269908DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Prof Peter Kelly
Mater Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2016
First Posted
September 13, 2016
Study Start
December 12, 2016
Primary Completion
January 31, 2024
Study Completion
January 31, 2024
Last Updated
March 13, 2025
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Within one year
A summary report of the trial will be provided to the Ethics Committees and relevant Regulatory Authority within as per national legal requirements in participating countries