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Trial record 1 of 1 for:    convince AND colchicine AND stroke
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Colchicine for Prevention of Vascular Inflammation in Non-cardio Embolic Stroke (CONVINCE)

This study is currently recruiting participants.
Verified September 2017 by University College Dublin
Sponsor:
ClinicalTrials.gov Identifier:
NCT02898610
First Posted: September 13, 2016
Last Update Posted: September 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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 Leuven
University of Athens
Information provided by (Responsible Party):
University College Dublin
  Purpose

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


Condition Intervention Phase
Ischemic Attack, Transient Stroke Drug: Colchicine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by University College Dublin:

Primary Outcome Measures:
  • Recurrence of non-fatal ischemic stroke [ Time Frame: any time within 60 month ]
    Any recurrence of non-fatal ischemic stroke

  • on-fatal Major Cardiac event [ Time Frame: any time within 60 months ]
    Non-fatal hospitalization for unstable angina, myocardial infarction, cardiac arrest

  • Vascular death [ Time Frame: 60 months ]
    Fatal ischemic stroke, myocardial infarction, cardiac arrest


Estimated Enrollment: 2623
Study Start Date: December 12, 2016
Estimated Study Completion Date: October 2021
Estimated Primary Completion Date: October 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Colchicine treatment
Colchicine 0.5mg/day plus usual care for 60 months
Drug: Colchicine
No Intervention: Usual Standard of care alone
Normal standard of care remains for these patients

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02898610


Contacts
Contact: Prof Peter Kelly isctn@ucd.ie
Contact: Prof Sean Murphy isctn@ucd.ie

Locations
Belgium
AZ Sint Jan Not yet recruiting
Brugge, Belgium
Principal Investigator: Geert Vanhooren         
AZ Groeninge Kortrijk Not yet recruiting
Kortrijk, Belgium
Principal Investigator: Peter Vanacker         
CHC Leige Recruiting
Leige, Belgium
Principal Investigator: Philippe Desfontaines         
UZ Leuven Recruiting
Leuven, Belgium
Principal Investigator: Robin Lemmens         
Ireland
Cork University Hospital Not yet recruiting
Cork, Ireland
Principal Investigator: Simon Cronin         
Letterkenny University Hospital Not yet recruiting
Donegal, Ireland
Principal Investigator: Jose Miranda         
Beaumont Hospital Recruiting
Dublin, Ireland
Principal Investigator: David Williams         
Connolly Hospital, Blanchardstown Recruiting
Dublin, Ireland
Principal Investigator: Eamon Dolan         
Mater Misericordiae University Hospital Recruiting
Dublin, Ireland
Contact: Sean Murphy         
St James's Hospital Recruiting
Dublin, Ireland
Principal Investigator: Joe Harbison         
St Vincent's University Hospital Recruiting
Dublin, Ireland
Contact: Tim Cassidy         
The Adelaide & Meath Hospital, Dublin incorporting the NCH Recruiting
Dublin, Ireland
Principal Investigator: Ronan Collins         
Galway University Hospital Recruiting
Galway, Ireland
Principal Investigator: Martin O'Donnell         
Naas General Hospital Not yet recruiting
Kildare, Ireland
Principal Investigator: Paul OBrien         
University Hospital Limerick Recruiting
Limerick, Ireland
Principal Investigator: John McManua         
Our Lady of Lourdes, Drogheda Recruiting
Louth, Ireland
Principal Investigator: Martin Mulroy         
Mayo University Hospital Not yet recruiting
Mayo, Ireland
Principal Investigator: Tom O'Malley         
Sligo University Hospital Recruiting
Sligo, Ireland
Principal Investigator: Paula Hickey         
South Tipperary General Hospital, Clonmel Recruiting
Tipperary, Ireland
Principal Investigator: Christina Donnellan         
University Hospital Waterford Recruiting
Waterford, Ireland
Principal Investigator: George Pope         
Spain
Hospital de Sant Pau Not yet recruiting
Barcelona, Spain
Principal Investigator: Joan Marti Fabgreas         
Hospital del Mar Not yet recruiting
Barcelona, Spain
Principal Investigator: Elisa Cuadrado         
Hospital de Arnau de Vilanova Not yet recruiting
Lleida, Spain
Principal Investigator: Francisco Purroy         
Sponsors and Collaborators
University College Dublin
Health Research Board, Ireland
Irish Heart Foundation
University of Limerick
University of Edinburgh
National University of Ireland, Galway, Ireland
Universitat de Lleida
Universitaire Ziekenhuizen Leuven
University of Athens
Investigators
Study Director: Prof Peter Kelly Mater Hospital
  More Information

Responsible Party: University College Dublin
ClinicalTrials.gov Identifier: NCT02898610     History of Changes
Other Study ID Numbers: 2015-004505-16
First Submitted: September 8, 2016
First Posted: September 13, 2016
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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

Additional relevant MeSH terms:
Stroke
Colchicine
Inflammation
Ischemic Attack, Transient
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Ischemia
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents