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Ischemic Attack, TransientPhase 3CONVINCENCT02898610

Colchicine for Prevention of Vascular Inflammation in Non-cardio Embolic Stroke

A Phase 3 study testing Colchicine in people with Ischemic Attack, Transient and Stroke, run by University College Dublin at 145 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Ischemic Attack, Transient, Stroke
What is being tested?
Colchicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,154 participants
Where
145 sitesin 14 countries
Study dates
12 Dec 2016to 31 Jan 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.
  • 9. Dementia, sufficient to impair independence in basic activities of daily living.
  • 10. Active malignancy, known hepatitis B or C, or HIV infection prior to qualifying stroke/TIA.
  • 11. 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.
  • 14. 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.

Trial locations and contacts

145 sites in 14 countries.

145 sites in 14 countries

United Kingdom59 sites

  • Bronglais General Hospital

    Aberystwyth

  • Aintree University Hospital

    Aintree

  • Monklands Hospital

    Airdrie

  • Antrim Area Hospital

    Antrim

  • William Harvey Hospital

    Ashford

  • Royal Victoria Hospital

    Belfast

  • Royal Blackburn Hospital

    Blackburn

  • Pilgrim Hospital

    Boston

  • Royal Bournemouth Hospital

    Bournemouth

  • West Suffolk Hospital

    Bury St Edmunds

  • Addenbrookes Hospital

    Cambridge

  • Kent and Canterbury Hospital

    Canterbury

  • Countess of Chester Hospital

    Chester

  • Chesterfield Royal Hospital

    Chesterfield

  • St Richards Hospital

    Chichester

  • Craigavon Area Hospital

    Craigavon

  • Northumbria Specialist Emergency Care Hospital

    Cramlington

  • Croydon University Hospital

    Croydon

  • Royal Derby Hospital

    Derby

  • North Durham University Hospital

    Durham

  • South West Acute Hospital

    Enniskillen

  • Royal Devon & Exeter Hospital

    Exeter

  • Queen Elizabeth Hospital Gateshead

    Gateshead

  • Medway Maritime Hospital

    Gillingham

  • Hairmyres Hospital

    Glasgow

  • Queen Elizabeth University Hospital Glasgow

    Glasgow

  • Wycombe Hospital

    High Wycombe

  • Raigmore Hospital

    Inverness

  • Kingston Hospital

    Kingston

  • Leicester Royal Infirmary

    Leicester

  • University Hospital Lewisham

    Lewisham

  • Lincoln County Hospital

    Lincoln

  • Royal Liverpool University Hospital

    Liverpool

  • Charing Cross Hospital

    London

  • King's College Hospital

    London

  • Royal London Hospital

    London

  • St George's Hospital

    London

  • St Thomas' Hospital

    London

  • University College London Hospital

    London

  • Altnagelvin Area Hospital

    Londonderry

  • Luton & Dunstable University Hospital

    Luton

  • Queen Elizabeth the Queen Mother Hospital

    Margate

  • Norfolk and Norwich Hospital

    Norwich

  • Nottingham City Hospital

    Nottingham

  • Peterborough Hospital

    Peterborough

  • Derriford Hospital

    Plymouth

  • Royal Hallamshire Hospital

    Sheffield

  • Southend University Hospital

    Southend

  • Stepping Hill Hospital

    Stockport

  • Royal Stoke University Hospital

    Stoke

  • Sunderland Royal Hospital

    Sunderland

  • King's Mill Hospital

    Sutton in Ashfield

  • Great Western Hospital

    Swindon

  • Princess Royal Hospital

    Telford

  • Royal Cornwall Hospital

    Truro

  • Whiston Hospital

    Whiston

  • New Cross Hospital

    Wolverhampton

  • Worthing Hospital

    Worthing

  • Yeovil District Hospital

    Yeovil

Other trials in United Kingdom

Germany23 sites

  • Rhön-Klinikum Campus Bad Neustadt

    Bad Neustadt an der Saale

  • Vivantes Auguste-Viktoria Klinikum

    Berlin

  • Vivantes Humboldt-Klinikum

    Berlin

  • Vivantes Klinikum Neukölln, Berlin

    Berlin

  • St. Josef-Hospital Klinikum der Ruhr-Universität Bochum

    Bochum

  • Universitätsklinikum Bonn

    Bonn

  • Krankenhaus Buchholz

    Buchholz

  • Klinikum Dortmund gGmbH

    Dortmund

  • Universitätsklinikum Essen

    Essen

  • Frankfurt University Hospital

    Frankfurt

  • Klinikum Fulda gAG, Universitätsmedizin Marburg-Campus Fulda

    Fulda

  • SRH Wald-Klinikum Gera GmbH

    Gera

  • Krakenhaus Martha Maria Halle Dolau

    Halle

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg

  • Medizinische Hochschule Hannover

    Hanover

  • Universitätsklinikum Heidelberg

    Heidelberg

  • Universitätsklinikum Leipzig AöR

    Leipzig

  • Klinikum Main-Spessart, Standort Krankenhaus Lohr

    Lohr

  • Universitätsklinikum Schleswig-Holstein, Campus Lübeck

    Lübeck

  • Klinikum der Universität München

    München

  • Mediclin-Fachklinik Rhein/Ruhr

    Rheine

  • Medinos Kliniken des Landkreises Sonneberg

    Sonneberg

  • Universitätsklinikum Würzburg

    Würzburg

Other trials in Germany

Ireland15 sites

  • Cavan General Hospital

    Cavan, Cavan

  • Cork University Hospital

    Cork

  • Beaumont Hospital

    Dublin

  • Connolly Hospital, Blanchardstown

    Dublin

  • Mater Misericordiae University Hospital

    Dublin

  • St James's Hospital

    Dublin

  • St Vincent's University Hospital

    Dublin

  • Tallaght University Hospital

    Dublin

  • Galway University Hospital

    Galway

  • St Lukes General Hospital

    Kilkenny

  • University Hospital Limerick

    Limerick

  • Our Lady of Lourdes, Drogheda

    Louth

  • Sligo University Hospital

    Sligo

  • South Tipperary General Hospital, Clonmel

    Tipperary

  • University Hospital Waterford

    Waterford

Other trials in Ireland

Spain13 sites

  • Complejo Hospitalario Universitario A Coruña

    A Coruña

  • H. de Albacete

    Albacete

  • Hospital de Sant Pau

    Barcelona

  • Hospital del Mar

    Barcelona

  • Hospital Moises Broggi. Comprehensive Health Consortium

    Barcelona

  • H U. Josep Trueta, Girona

    Girona

  • Hospital Universitari Arnau de Vilanova de Lleida

    Lleida

  • H. U. Ramón y Cajal, Madrid

    Madrid

  • Centro Medico de Asturias

    Oviedo

  • H Parc Taulí de Sabadell

    Sabadell

  • H U. Virgen del Rocío, Sevilla

    Seville

  • Hospital Virgen Macarena Sevilla

    Seville

  • H Joan XXIII, Tarragona

    Tarragona

Other trials in Spain

Belgium11 sites

  • Uza, Antwerpen

    Antwerp

  • AZ Sint Jan

    Bruges

  • AZ St. Lucas, BRUGGE

    Bruges

  • UCL, Brussels

    Brussels

  • UZ Brussel

    Brussels

  • UZ Gent

    Ghent

  • AZ Groeninge Kortrijk

    Kortrijk

  • UZ Leuven

    Leuven

  • CHC Liege

    Liège

  • AZ Damiaan, OOSTENDE

    Ostend

  • AZ Delta, ROESELARE

    Roeselare

Other trials in Belgium

Denmark4 sites

  • Bispebjerg Hospital

    Bispebjerg

  • Rigshospitalet Glostrup

    Glostrup Municipality

  • Herlev Hospital

    Herlev

  • Nordsjællands Hospital

    Hillerød

Other trials in Denmark

Netherlands4 sites

  • Academic Medical Center

    Amsterdam

  • Gelre Ziekenhuis Apeldoorn

    Apeldoorn

  • Reinier de Graaf Hospital

    Delft

  • Radboud University Medical Centre

    Nijmegen

Other trials in Netherlands

Poland4 sites

  • Hospital Nicholas Copernicus

    Gdansk

  • Specialist Hospital of Saint Luke

    Gmina Końskie

  • Medical University of Silesia Hospital No7

    Rokietnica

  • Institute of Psychiatry and Neurology

    Warsaw

Other trials in Poland

Canada3 sites

  • Foothills Medical Centre, Calgary

    Calgary

  • Kingston Hospital

    Kingston

  • Vancouver General Hospital

    Vancouver

Other trials in Canada

Portugal3 sites

  • Hospital de Santa Maria, Centro Hospitalar Lisboa Norte

    Lisbon

  • Hospital Egas Moniz

    Lisbon

  • Hospital Universitario de Sao Jao

    Porto

Other trials in Portugal

Czechia2 sites

  • St. Anne´s University Hospital

    Brno

  • Hospital Jihlava

    Jihlava

Other trials in Czechia

Lithuania2 sites

  • Lithuanian University Hospital of Health Sciences Kaunos Klinikos

    Kaunas

  • Vilnius University Hospital Santaros Clinics

    Vilnius

Other trials in Lithuania

Estonia1 site

  • Tartu University Hospital

    Tartu

Other trials in Estonia

Switzerland1 site

  • University Hospital Bern

    Bern

Other trials in Switzerland

About this study

Official title: CONVINCE - (COlchicine for preventioN of Vascular Inflammation in Non- CardioEmbolic Stroke) - a Randomised Clinical Trial of Low-dose Colchicine for Secondary Prevention After Stroke

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

Read the detailed description

Inflammation is a key pathophysiological contributor to unstable atherosclerotic plaque and thrombo-embolic events, stroke, myocardial infarction, and vascular death. Internationally, clinical trials are targeting atherosclerotic inflammation in patients with coronary disease using methotrexate, colchicine, and canukinumab.

Aims:

The primary aim is to compare low-dose colchicine (0.5mg/day) plus usual care, to usual care alone, to prevent non-fatal recurrent ischaemic stroke and coronary events and vascular death after non-severe, noncardioembolic TIA/stroke. Secondary objectives will investigate safety of low-dose colchicine, and efficacy for each component of the primary outcome, fatal and non-fatal events, disabling and non-disabling stroke, effect modification by prespecified subgroups, and impact on direct health care costs, adjusted for quality-adjusted life years.

Being tested
Colchicine
Medical subject headings
Ischemic Attack, Transient, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ColchicineDrug

Study groups in NCT02898610
Study groupRoleWhat they receive
Colchicine treatmentActive comparatorColchicine 0.5mg/day plus usual care for 60 months
Receives: Drug: Colchicine
Usual Standard of care aloneNo interventionNormal standard of care remains for these patients

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrence of non-fatal ischemic stroke

    Any recurrence of non-fatal ischemic stroke

    Measured: any time within 60 month

  2. on-fatal Major Cardiac event

    Non-fatal hospitalization for unstable angina, myocardial infarction, cardiac arrest

    Measured: any time within 60 months

  3. Vascular death

    Fatal ischemic stroke, myocardial infarction, cardiac arrest

    Measured: 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2016 (estimated)
  2. Study start12 Dec 2016
  3. Primary completion31 Jan 2024
  4. Study completion31 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
3,154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02898610
Sponsor's protocol ID
2015-004505-16
Other IDs
2015
Acronym
CONVINCE
Status last verified
Jun 2024
First submitted
8 Sep 2016
Last updated
13 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • 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.

    PubMed 38857611

  • Maes L, Wouters A, Peluso JP, Demeestere J, Desfontaines P, De Pauw A, Collins R, McCabe DJH, Cronin S, Williams DJ, De Raedt S, Purroy F, Vanhooren G, Pope G, Vanacker P, Cassidy T, Nerney D, Walsh C, Bos D, Kelly P, Lemmens R. Computed-Tomography Angiography-Based Carotid Plaque-RADS, Recurrent Vascular Events, and the Effect of Colchicine: An Imaging Substudy of the CONVINCE Randomized Trial. Stroke. 2026 Oct 22. doi: 10.1161/STROKEAHA.126.057740. Online ahead of print.

    PubMed 42910427

  • McCabe JJ, Lemmens R, Purroy F, Walsh C, Weimar C, Czlonkowska A, Fischer U, Fonseca C, Hill MD, Jatuzis D, Korv J, Kruuse C, Mikulik R, Navabi D, Harbison J, O'Connor M, Iversen HK, Adie K, Nederkoorn P, Price C, Kelly PJ. Colchicine for Secondary Prevention After Stroke According to the Presence of Atherosclerosis. Stroke. 2026 Aug 20. doi: 10.1161/STROKEAHA.126.056561. Online ahead of print.

    PubMed 42619594

  • Synnott P, Walsh C, Weimar C, Purroy F, Price C, Fonseca AC, Hill M, Jatuzis D, Korv J, Kruuse C, Mikulik R, Nederkoorn P, Czlonkowska A, Fischer U, Nabavi DG, Harbison J, Cassidy T, O'Connor M, Iversen HK, Adie K, Lemmens R, Kelly PJ; CONVINCE investigators. Contemporary achievement of guideline recommendations for blood pressure management after stroke in the CONVINCE trial. Eur Stroke J. 2026 Jul 6;11(7):aakag051. doi: 10.1093/esj/aakag051.

    PubMed 42418305

  • Maes L, Verschuere C, Walsh C, Weimar C, Purroy F, Price C, Fonseca C, Hill MD, Jatuzis D, Korv J, Kruuse C, Mikulik R, Nederkoorn P, Czlonkowska A, Fischer U, McCormick M, Castellanos M, Baptista M, Marto JP, Thavanesan K, Williams DJ, Kelly P, Lemmens R; CONVINCE investigators. Validation of the SMART-REACH model after stroke and the effect of colchicine by atherosclerotic cardiovascular disease risk category: a secondary analysis of the CONVINCE randomised clinical trial. Eur Stroke J. 2026 Apr 6;11(4):aakag033. doi: 10.1093/esj/aakag033.

    PubMed 42032972

  • Maes 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. 2026 Aug;21(7):1009-1018. doi: 10.1177/17474930251406818. Epub 2025 Dec 2.

    PubMed 41328787

  • Akl 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.

    PubMed 38505729

  • Bouabdallaoui 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.

    PubMed 34269908

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Colchicine in people with Ischemic Attack, Transient and Stroke, run by University College Dublin at 145 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 145 sites in United Kingdom, Germany, Ireland, Spain, Belgium and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence of non-fatal ischemic stroke (time frame: any time within 60 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02898610, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.

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