Colchicine for prevention of vascular inflammation in Non-CardioEmbolic stroke (CONVINCE) – study protocol for a randomised controlled trial

Peter Kelly, Christian Weimar, Robin Lemmens, Sean Murphy, Francisco Purroy, Anita Arsovska, Natan M Bornstein, Anna Czlonkowska, Urs Fischer, Ana Catarina Fonseca, John Forbes, Michael D Hill, Dalius Jatuzis, Janika Kõrv, Christina Kruuse, Robert Mikulik, Paul J Nederkoorn, Martin O’donnell, Peter Sandercock, David TanneGeorgios Tsivgoulis, Cathal Walsh, David Williams, Marialuisa Zedde, Christopher I Price

Research output: Contribution to journalArticlepeer-review

Abstract / Description of output


Inflammation contributes to unstable atherosclerotic plaque and stroke. In randomised trials in patients with coronary disease, canukinumab (an interleukin-1B antagonist) and colchicine (a tubulin inhibitor with pleiotropic anti-inflammatory effects) reduced recurrent vascular events.

Hypothesis: Anti-inflammatory therapy with low-dose colchicine plus usual care will reduce recurrent vascular events in patients with non-severe, non-cardioembolic stroke and TIA compared with usual care alone.

CONVINCE is a multi-centre international (in 17 countries) Prospective, Randomised Open-label, Blinded-Endpoint assessment (PROBE) controlled Phase 3 clinical trial in 3154 participants. The intervention is colchicine 0.5 mg/day and usual care versus usual care alone (antiplatelet, lipid-lowering, antihypertensive treatment, lifestyle advice). Included patients are at least 40 years, with non-severe ischaemic stroke (modified Rankin score ≤3) or high-risk TIA (ABCD2 > 3, or positive DWI, or cranio-cervical artery stenosis) within 72 hours-28 days of randomisation, with qualifying stroke/TIA most likely caused by large artery stenosis, lacunar disease, or cryptogenic embolism. Exclusions are stroke/TIA caused by cardio-embolism or other defined cause (e.g. dissection), contra-indication to colchicine (including potential drug interactions), or incapacity for participation in a clinical trial. The anticipated median follow-up will be 36 months. The primary analysis will be by intention-to-treat.

The primary outcome is time to first recurrent ischaemic stroke, myocardial infarction, cardiac arrest, or hospitalisation with unstable angina (non-fatal or fatal).

CONVINCE will provide high-quality randomised data on the efficacy and safety of anti-inflammatory therapy with colchicine for secondary prevention after stroke.

First-patient first-visit was December 2016. Recruitment to complete in 2021, follow-up to complete in 2023.
Original languageEnglish
Pages (from-to)222-228
Number of pages7
JournalEuropean Stroke Journal
Issue number2
Early online date18 Jun 2021
Publication statusE-pub ahead of print - 18 Jun 2021

Keywords / Materials (for Non-textual outputs)

  • Ischaemic stroke
  • inflammation
  • colchicine
  • randomised controlled trial


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