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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 not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2016 by University College Dublin
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
ClinicalTrials.gov Identifier:
NCT02898610
First received: September 8, 2016
Last updated: October 24, 2016
Last verified: October 2016
  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: 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: October 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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02898610

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

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
Study First Received: September 8, 2016
Last Updated: October 24, 2016
Individual Participant Data  
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

ClinicalTrials.gov processed this record on April 27, 2017