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
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 or disease||Intervention/treatment||Phase|
|Ischemic Attack, Transient Stroke||Drug: Colchicine||Phase 3|
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.
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2623 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||December 12, 2016|
|Estimated Primary Completion Date :||October 2021|
|Estimated Study Completion Date :||October 2021|
Active Comparator: Colchicine treatment
Colchicine 0.5mg/day plus usual care for 60 months
No Intervention: Usual Standard of care alone
Normal standard of care remains for these patients
- 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
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
|Contact: Prof Peter Kellyfirstname.lastname@example.org|
|Contact: Prof Sean Murphyemail@example.com|
|Study Director:||Prof Peter Kelly||Mater Hospital|