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Trial record 2 of 2 for:    colchicine | stroke

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

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ClinicalTrials.gov Identifier: NCT02898610
Recruitment Status : Recruiting
First Posted : September 13, 2016
Last Update Posted : September 25, 2017
Sponsor:
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

Tracking Information
First Submitted Date  ICMJE September 8, 2016
First Posted Date  ICMJE September 13, 2016
Last Update Posted Date September 25, 2017
Study Start Date  ICMJE December 12, 2016
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2016)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Colchicine for Prevention of Vascular Inflammation in Non-cardio Embolic Stroke
Official Title  ICMJE CONVINCE - (COlchicine for preventioN of Vascular Inflammation in Non- CardioEmbolic Stroke) - a Randomised Clinical Trial of Low-dose Colchicine for Secondary Prevention After Stroke
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Ischemic Attack, Transient
  • Stroke
Intervention  ICMJE Drug: Colchicine
Study Arms  ICMJE
  • Active Comparator: Colchicine treatment
    Colchicine 0.5mg/day plus usual care for 60 months
    Intervention: Drug: Colchicine
  • No Intervention: Usual Standard of care alone
    Normal standard of care remains for these patients
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 12, 2016)
2623
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Prof Peter Kelly isctn@ucd.ie
Contact: Prof Sean Murphy isctn@ucd.ie
Listed Location Countries  ICMJE Belgium,   Ireland,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02898610
Other Study ID Numbers  ICMJE 2015-004505-16
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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
Responsible Party University College Dublin
Study Sponsor  ICMJE University College Dublin
Collaborators  ICMJE
  • 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  ICMJE
Study Director: Prof Peter Kelly Mater Hospital
PRS Account University College Dublin
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP