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

Primary Purpose

Ischemic Attack, Transient, Stroke

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Colchicine
Sponsored by
University College Dublin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ischemic Attack, Transient

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Written informed consent consistent with ICH-GCP guidelines and local laws signed prior to all trial-related procedures.
  2. Age 40 years or greater

  3. Either,

    • ischaemic stroke without major disability (modified Rankin score 3 or less)
    • or high-risk TIA
  4. 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.
  5. GFRgreater than or equal to 50 ml/min.
  6. In the opinion of the treating physician, patient is medically-stable, capable of participating in a randomised trial, and willing to attend follow-up.

Exclusion Criteria:

  1. Cardio-embolic stroke/TIA, probably caused by identified atrial fibrillation (permanent or paroxysmal), in the opinion of the treating physician.
  2. 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.
  3. 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.
  4. History of myopathy or myalgias with raised creatine kinase (CK) on statin therapy.
  5. Blood dyscrasia defined as anaemia (haemoglobin <10g/dL), thrombocytopenia (platelet count <150 x109/L) or leucopenia (white cell count <4 x109/L) at randomisation.
  6. Impaired hepatic function (transaminases greater than twice upper limit of normal) at randomisation.
  7. 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.
  8. Symptomatic peripheral neuropathy and pre-existing progressive neuromuscular disease
  9. 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.

Sites / Locations

  • Uza, Antwerpen
  • AZ Sint Jan
  • AZ St. Lucas, BRUGGE
  • UCL, Brussels
  • UZ Brussel
  • UZ Gent
  • AZ Groeninge Kortrijk
  • UZ Leuven
  • CHC Liege
  • AZ Damiaan, OOSTENDE
  • AZ Delta, ROESELARE
  • Foothills Medical Centre, Calgary
  • Kingston Hospital
  • Vancouver General Hospital
  • St. Anne´s University Hospital
  • Hospital Jihlava
  • Bispebjerg Hospital
  • Rigshospitalet Glostrup
  • Herlev Hospital
  • Nordsjællands Hospital
  • Astra Team Clinic
  • Tartu University Hospital
  • Rhön-Klinikum Campus Bad Neustadt
  • Vivantes Auguste-Viktoria Klinikum
  • Vivantes Humboldt-Klinikum
  • Vivantes Klinikum Neukölln, Berlin
  • Evangelisches Krankenhaus Bielefeld gGmbH
  • St. Josef-Hospital Klinikum der Ruhr-Universität Bochum
  • Universitätsklinikum Bonn
  • Krankenhaus Buchholz
  • Allgemeines Krankenhaus Celle
  • Klinikum Dortmund gGmbH
  • Universitätsklinikum Essen
  • Frankfurt University Hospital
  • Klinikum Fulda gAG, Universitätsmedizin Marburg-Campus Fulda
  • SRH Wald-Klinikum Gera GmbH
  • Krakenhaus Martha Maria Halle Dolau
  • Universitätsklinikum Hamburg-Eppendorf
  • Medizinische Hochschule Hannover
  • Universitätsklinikum Heidelberg
  • Universitätsklinikum Leipzig AöR
  • Klinikum Main-Spessart, Standort Krankenhaus Lohr
  • Universitätsklinikum Schleswig-Holstein, Campus Lübeck
  • Universitätsklinikum Magdeburg A.ö.R.
  • Klinikum der Universität München
  • Mediclin-Fachklinik Rhein/Ruhr
  • Medinos Kliniken des Landkreises Sonneberg
  • Universitätsklinikum Würzburg
  • Cavan General Hospital
  • Cork University Hospital
  • Beaumont Hospital
  • Connolly Hospital, Blanchardstown
  • Mater Misericordiae University Hospital
  • St James's Hospital
  • St Vincent's University Hospital
  • Tallaght University Hospital
  • Galway University Hospital
  • St Lukes General Hospital
  • University Hospital Limerick
  • Our Lady of Lourdes, Drogheda
  • Sligo University Hospital
  • South Tipperary General Hospital, Clonmel
  • University Hospital Waterford
  • Lithuanian University Hospital of Health Sciences Kaunos Klinikos
  • Republican Vilnius University Hospital
  • Vilnius University Hospital Santaros Clinics
  • Academic Medical Center
  • Gelre Ziekenhuis Apeldoorn
  • Reinier de Graaf Hospital
  • University Medical Centre
  • Hospital Nicholas Copernicus
  • Specialist Hospital of Saint Luke
  • Medical University of Silesia Hospital No7
  • Institute of Psychiatry and Neurology
  • Centro Hospitalar e Universitario de Coimbra
  • Hospital Beatriz Angelo
  • Hospital de Santa Maria, Centro Hospitalar Lisboa Norte
  • Hospital Egas Moniz
  • Hospital Universitario de Sao Jao
  • H. de Albacete
  • Hospital de Sant Pau
  • Hospital del Mar
  • Hospital Moises Broggi. Comprehensive Health Consortium
  • Complejo Hospitalario Universitario A Coruña
  • H U. Josep Trueta, Girona
  • Hospital Universitari Arnau de Vilanova de Lleida
  • H. U. Ramón y Cajal, Madrid
  • Centro Medico de Asturias
  • H Parc Taulí de Sabadell
  • H U. Virgen del Rocío, Sevilla
  • Hospital Virgen Macarena Sevilla
  • H Joan XXIII, Tarragona
  • University Hospital Bern
  • Bronglais General Hospital
  • Aintree University Hospital
  • Monklands Hospital
  • Antrim Area Hospital
  • William Harvey Hospital
  • Royal Victoria Hospital
  • Royal Blackburn Hospital
  • Pilgrim Hospital
  • Royal Bournemouth Hospital
  • West Suffolk Hospital
  • Addenbrookes Hospital
  • Kent and Canterbury Hospital
  • Chesterfield Royal Hospital
  • Countess of Chester Hospital
  • St Richards Hospital
  • Craigavon Area Hospital
  • Northumbria Specialist Emergency Care Hospital
  • Croydon University Hospital
  • Royal Derby Hospital
  • Altnagelvin Area Hospital
  • North Durham University Hospital
  • South West Acute Hospital
  • Royal Devon & Exeter Hospital
  • Queen Elizabeth Hospital Gateshead
  • Medway Maritime Hospital
  • Hairmyres Hospital
  • Queen Elizabeth University Hospital Glasgow
  • Wycombe Hospital
  • Raigmore Hospital
  • Kingston Hospital
  • Leicester Royal Infirmary
  • University Hospital Lewisham
  • Lincoln County Hospital
  • Royal Liverpool University Hospital
  • Charing Cross Hospital
  • King's College Hospital
  • Royal London Hospital
  • St George's Hospital
  • St Thomas' Hospital
  • University College London Hospital
  • Luton & Dunstable University Hospital
  • Maidstone & District General Hospital
  • Queen Elizabeth the Queen Mother Hospital
  • Norfolk and Norwich Hospital
  • Nottingham City Hospital
  • Peterborough Hospital
  • Derriford Hospital
  • Royal Hallamshire Hospital
  • Southend University Hospital
  • Stepping Hill Hospital
  • Royal Stoke University Hospital
  • Sunderland Royal Hospital
  • King's Mill Hospital
  • Great Western Hospital
  • Princess Royal Hospital
  • Royal Cornwall Hospital
  • Whiston Hospital
  • New Cross Hospital
  • Worthing Hospital
  • Yeovil District Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Colchicine treatment

Usual Standard of care alone

Arm Description

Colchicine 0.5mg/day plus usual care for 60 months

Normal standard of care remains for these patients

Outcomes

Primary Outcome Measures

Recurrence of non-fatal ischemic stroke
Any recurrence of non-fatal ischemic stroke
on-fatal Major Cardiac event
Non-fatal hospitalization for unstable angina, myocardial infarction, cardiac arrest
Vascular death
Fatal ischemic stroke, myocardial infarction, cardiac arrest

Secondary Outcome Measures

Full Information

First Posted
September 8, 2016
Last Updated
February 27, 2023
Sponsor
University College Dublin
Collaborators
Health Research Board, Ireland, Irish Heart Foundation, University of Limerick, University of Edinburgh, National University of Ireland, Galway, Ireland, Universitat de Lleida, Universitaire Ziekenhuizen KU Leuven, University of Athens
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1. Study Identification

Unique Protocol Identification Number
NCT02898610
Brief Title
Colchicine for Prevention of Vascular Inflammation in Non-cardio Embolic Stroke
Acronym
CONVINCE
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 12, 2016 (Actual)
Primary Completion Date
November 21, 2022 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College Dublin
Collaborators
Health Research Board, Ireland, Irish Heart Foundation, University of Limerick, University of Edinburgh, National University of Ireland, Galway, Ireland, Universitat de Lleida, Universitaire Ziekenhuizen KU Leuven, University of Athens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Attack, Transient, Stroke

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Colchicine treatment
Arm Type
Active Comparator
Arm Description
Colchicine 0.5mg/day plus usual care for 60 months
Arm Title
Usual Standard of care alone
Arm Type
No Intervention
Arm Description
Normal standard of care remains for these patients
Intervention Type
Drug
Intervention Name(s)
Colchicine
Primary Outcome Measure Information:
Title
Recurrence of non-fatal ischemic stroke
Description
Any recurrence of non-fatal ischemic stroke
Time Frame
any time within 60 month
Title
on-fatal Major Cardiac event
Description
Non-fatal hospitalization for unstable angina, myocardial infarction, cardiac arrest
Time Frame
any time within 60 months
Title
Vascular death
Description
Fatal ischemic stroke, myocardial infarction, cardiac arrest
Time Frame
60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof Peter Kelly
Organizational Affiliation
Mater Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Uza, Antwerpen
City
Antwerp
Country
Belgium
Facility Name
AZ Sint Jan
City
Brugge
Country
Belgium
Facility Name
AZ St. Lucas, BRUGGE
City
Brugge
Country
Belgium
Facility Name
UCL, Brussels
City
Brussels
Country
Belgium
Facility Name
UZ Brussel
City
Brussels
Country
Belgium
Facility Name
UZ Gent
City
Gent
Country
Belgium
Facility Name
AZ Groeninge Kortrijk
City
Kortrijk
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
Country
Belgium
Facility Name
CHC Liege
City
Liège
Country
Belgium
Facility Name
AZ Damiaan, OOSTENDE
City
Oostende
Country
Belgium
Facility Name
AZ Delta, ROESELARE
City
Roeselare
Country
Belgium
Facility Name
Foothills Medical Centre, Calgary
City
Calgary
Country
Canada
Facility Name
Kingston Hospital
City
Kingston
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
Country
Canada
Facility Name
St. Anne´s University Hospital
City
Brno
Country
Czechia
Facility Name
Hospital Jihlava
City
Jihlava
Country
Czechia
Facility Name
Bispebjerg Hospital
City
Bispebjerg
Country
Denmark
Facility Name
Rigshospitalet Glostrup
City
Glostrup
Country
Denmark
Facility Name
Herlev Hospital
City
Herlev
Country
Denmark
Facility Name
Nordsjællands Hospital
City
Hillerød
Country
Denmark
Facility Name
Astra Team Clinic
City
Tallinn
Country
Estonia
Facility Name
Tartu University Hospital
City
Tartu
Country
Estonia
Facility Name
Rhön-Klinikum Campus Bad Neustadt
City
Bad Neustadt An Der Saale
Country
Germany
Facility Name
Vivantes Auguste-Viktoria Klinikum
City
Berlin
Country
Germany
Facility Name
Vivantes Humboldt-Klinikum
City
Berlin
Country
Germany
Facility Name
Vivantes Klinikum Neukölln, Berlin
City
Berlin
Country
Germany
Facility Name
Evangelisches Krankenhaus Bielefeld gGmbH
City
Bielefeld
Country
Germany
Facility Name
St. Josef-Hospital Klinikum der Ruhr-Universität Bochum
City
Bochum
Country
Germany
Facility Name
Universitätsklinikum Bonn
City
Bonn
Country
Germany
Facility Name
Krankenhaus Buchholz
City
Buchholz
Country
Germany
Facility Name
Allgemeines Krankenhaus Celle
City
Celle
Country
Germany
Facility Name
Klinikum Dortmund gGmbH
City
Dortmund
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
Country
Germany
Facility Name
Frankfurt University Hospital
City
Frankfurt
Country
Germany
Facility Name
Klinikum Fulda gAG, Universitätsmedizin Marburg-Campus Fulda
City
Fulda
Country
Germany
Facility Name
SRH Wald-Klinikum Gera GmbH
City
Gera
Country
Germany
Facility Name
Krakenhaus Martha Maria Halle Dolau
City
Halle
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
Country
Germany
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
Country
Germany
Facility Name
Universitätsklinikum Leipzig AöR
City
Leipzig
Country
Germany
Facility Name
Klinikum Main-Spessart, Standort Krankenhaus Lohr
City
Lohr
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
City
Lübeck
Country
Germany
Facility Name
Universitätsklinikum Magdeburg A.ö.R.
City
Magdeburg
Country
Germany
Facility Name
Klinikum der Universität München
City
München
Country
Germany
Facility Name
Mediclin-Fachklinik Rhein/Ruhr
City
Rheine
Country
Germany
Facility Name
Medinos Kliniken des Landkreises Sonneberg
City
Sonneberg
Country
Germany
Facility Name
Universitätsklinikum Würzburg
City
Würzburg
Country
Germany
Facility Name
Cavan General Hospital
City
Cavan
Country
Ireland
Facility Name
Cork University Hospital
City
Cork
Country
Ireland
Facility Name
Beaumont Hospital
City
Dublin
Country
Ireland
Facility Name
Connolly Hospital, Blanchardstown
City
Dublin
Country
Ireland
Facility Name
Mater Misericordiae University Hospital
City
Dublin
Country
Ireland
Facility Name
St James's Hospital
City
Dublin
Country
Ireland
Facility Name
St Vincent's University Hospital
City
Dublin
Country
Ireland
Facility Name
Tallaght University Hospital
City
Dublin
Country
Ireland
Facility Name
Galway University Hospital
City
Galway
Country
Ireland
Facility Name
St Lukes General Hospital
City
Kilkenny
Country
Ireland
Facility Name
University Hospital Limerick
City
Limerick
Country
Ireland
Facility Name
Our Lady of Lourdes, Drogheda
City
Louth
Country
Ireland
Facility Name
Sligo University Hospital
City
Sligo
Country
Ireland
Facility Name
South Tipperary General Hospital, Clonmel
City
Tipperary
Country
Ireland
Facility Name
University Hospital Waterford
City
Waterford
Country
Ireland
Facility Name
Lithuanian University Hospital of Health Sciences Kaunos Klinikos
City
Kaunas
Country
Lithuania
Facility Name
Republican Vilnius University Hospital
City
Vilnius
Country
Lithuania
Facility Name
Vilnius University Hospital Santaros Clinics
City
Vilnius
Country
Lithuania
Facility Name
Academic Medical Center
City
Amsterdam
Country
Netherlands
Facility Name
Gelre Ziekenhuis Apeldoorn
City
Apeldoorn
Country
Netherlands
Facility Name
Reinier de Graaf Hospital
City
Delft
Country
Netherlands
Facility Name
University Medical Centre
City
Utrecht
Country
Netherlands
Facility Name
Hospital Nicholas Copernicus
City
Gdańsk
Country
Poland
Facility Name
Specialist Hospital of Saint Luke
City
Końskie
Country
Poland
Facility Name
Medical University of Silesia Hospital No7
City
Rokietnica
Country
Poland
Facility Name
Institute of Psychiatry and Neurology
City
Warsaw
Country
Poland
Facility Name
Centro Hospitalar e Universitario de Coimbra
City
Coimbra
Country
Portugal
Facility Name
Hospital Beatriz Angelo
City
Lisboa
Country
Portugal
Facility Name
Hospital de Santa Maria, Centro Hospitalar Lisboa Norte
City
Lisboa
Country
Portugal
Facility Name
Hospital Egas Moniz
City
Lisboa
Country
Portugal
Facility Name
Hospital Universitario de Sao Jao
City
Porto
Country
Portugal
Facility Name
H. de Albacete
City
Albacete
Country
Spain
Facility Name
Hospital de Sant Pau
City
Barcelona
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
Country
Spain
Facility Name
Hospital Moises Broggi. Comprehensive Health Consortium
City
Barcelona
Country
Spain
Facility Name
Complejo Hospitalario Universitario A Coruña
City
Coruna
Country
Spain
Facility Name
H U. Josep Trueta, Girona
City
Girona
Country
Spain
Facility Name
Hospital Universitari Arnau de Vilanova de Lleida
City
Lleida
Country
Spain
Facility Name
H. U. Ramón y Cajal, Madrid
City
Madrid
Country
Spain
Facility Name
Centro Medico de Asturias
City
Oviedo
Country
Spain
Facility Name
H Parc Taulí de Sabadell
City
Sabadell
Country
Spain
Facility Name
H U. Virgen del Rocío, Sevilla
City
Sevilla
Country
Spain
Facility Name
Hospital Virgen Macarena Sevilla
City
Sevilla
Country
Spain
Facility Name
H Joan XXIII, Tarragona
City
Tarragona
Country
Spain
Facility Name
University Hospital Bern
City
Bern
Country
Switzerland
Facility Name
Bronglais General Hospital
City
Aberystwyth
Country
United Kingdom
Facility Name
Aintree University Hospital
City
Aintree
Country
United Kingdom
Facility Name
Monklands Hospital
City
Airdrie
Country
United Kingdom
Facility Name
Antrim Area Hospital
City
Antrim
Country
United Kingdom
Facility Name
William Harvey Hospital
City
Ashford
Country
United Kingdom
Facility Name
Royal Victoria Hospital
City
Belfast
Country
United Kingdom
Facility Name
Royal Blackburn Hospital
City
Blackburn
Country
United Kingdom
Facility Name
Pilgrim Hospital
City
Boston
Country
United Kingdom
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
Country
United Kingdom
Facility Name
West Suffolk Hospital
City
Bury Saint Edmunds
Country
United Kingdom
Facility Name
Addenbrookes Hospital
City
Cambridge
Country
United Kingdom
Facility Name
Kent and Canterbury Hospital
City
Canterbury
Country
United Kingdom
Facility Name
Chesterfield Royal Hospital
City
Chesterfield
Country
United Kingdom
Facility Name
Countess of Chester Hospital
City
Chester
Country
United Kingdom
Facility Name
St Richards Hospital
City
Chichester
Country
United Kingdom
Facility Name
Craigavon Area Hospital
City
Craigavon
Country
United Kingdom
Facility Name
Northumbria Specialist Emergency Care Hospital
City
Cramlington
Country
United Kingdom
Facility Name
Croydon University Hospital
City
Croydon
Country
United Kingdom
Facility Name
Royal Derby Hospital
City
Derby
Country
United Kingdom
Facility Name
Altnagelvin Area Hospital
City
Derry
Country
United Kingdom
Facility Name
North Durham University Hospital
City
Durham
Country
United Kingdom
Facility Name
South West Acute Hospital
City
Enniskillen
Country
United Kingdom
Facility Name
Royal Devon & Exeter Hospital
City
Exeter
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital Gateshead
City
Gateshead
Country
United Kingdom
Facility Name
Medway Maritime Hospital
City
Gillingham
Country
United Kingdom
Facility Name
Hairmyres Hospital
City
Glasgow
Country
United Kingdom
Facility Name
Queen Elizabeth University Hospital Glasgow
City
Glasgow
Country
United Kingdom
Facility Name
Wycombe Hospital
City
High Wycombe
Country
United Kingdom
Facility Name
Raigmore Hospital
City
Inverness
Country
United Kingdom
Facility Name
Kingston Hospital
City
Kingston
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
Country
United Kingdom
Facility Name
University Hospital Lewisham
City
Lewisham
Country
United Kingdom
Facility Name
Lincoln County Hospital
City
Lincoln
Country
United Kingdom
Facility Name
Royal Liverpool University Hospital
City
Liverpool
Country
United Kingdom
Facility Name
Charing Cross Hospital
City
London
Country
United Kingdom
Facility Name
King's College Hospital
City
London
Country
United Kingdom
Facility Name
Royal London Hospital
City
London
Country
United Kingdom
Facility Name
St George's Hospital
City
London
Country
United Kingdom
Facility Name
St Thomas' Hospital
City
London
Country
United Kingdom
Facility Name
University College London Hospital
City
London
Country
United Kingdom
Facility Name
Luton & Dunstable University Hospital
City
Luton
Country
United Kingdom
Facility Name
Maidstone & District General Hospital
City
Maidstone
Country
United Kingdom
Facility Name
Queen Elizabeth the Queen Mother Hospital
City
Margate
Country
United Kingdom
Facility Name
Norfolk and Norwich Hospital
City
Norwich
Country
United Kingdom
Facility Name
Nottingham City Hospital
City
Nottingham
Country
United Kingdom
Facility Name
Peterborough Hospital
City
Peterborough
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital
City
Sheffield
Country
United Kingdom
Facility Name
Southend University Hospital
City
Southend
Country
United Kingdom
Facility Name
Stepping Hill Hospital
City
Stockport
Country
United Kingdom
Facility Name
Royal Stoke University Hospital
City
Stoke
Country
United Kingdom
Facility Name
Sunderland Royal Hospital
City
Sunderland
Country
United Kingdom
Facility Name
King's Mill Hospital
City
Sutton In Ashfield
Country
United Kingdom
Facility Name
Great Western Hospital
City
Swindon
Country
United Kingdom
Facility Name
Princess Royal Hospital
City
Telford
Country
United Kingdom
Facility Name
Royal Cornwall Hospital
City
Truro
Country
United Kingdom
Facility Name
Whiston Hospital
City
Whiston
Country
United Kingdom
Facility Name
New Cross Hospital
City
Wolverhampton
Country
United Kingdom
Facility Name
Worthing Hospital
City
Worthing
Country
United Kingdom
Facility Name
Yeovil District Hospital
City
Yeovil
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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
Citations:
PubMed Identifier
34269908
Citation
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.
Results Reference
derived

Learn more about this trial

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

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