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

Peter Kelly1,2, Christian Weimar3, Robin Lemmens4,4,5

  • 1Mater University Hospital and University College Dublin, Ireland.

European Stroke Journal
|August 20, 2021
PubMed
Abstract

Insights

Low-dose colchicine may reduce recurrent vascular events in patients with stroke or TIA. The CONVINCE trial investigates this anti-inflammatory therapy for secondary prevention in a large international study.

Area of Science:

  • Cardiovascular Medicine
  • Neurology
  • Pharmacology

Background:

  • Inflammation plays a key role in atherosclerotic plaque instability and stroke pathogenesis.
  • Previous trials show anti-inflammatory agents like canakinumab and colchicine reduce vascular events in coronary disease.
  • The hypothesis is that low-dose colchicine plus usual care reduces recurrent vascular events in specific stroke/TIA patients.

Purpose of the Study:

  • To evaluate the efficacy and safety of low-dose colchicine for secondary prevention in patients with non-severe, non-cardioembolic stroke and TIA.
  • To compare colchicine plus usual care against usual care alone in this patient population.

Main Methods:

  • The CONVINCE trial is a multi-centre, international, prospective, randomised, open-label, blinded-endpoint Phase 3 clinical trial.
  • 3154 participants aged ≥40 years with recent non-severe ischaemic stroke or high-risk TIA were randomized.
  • Intervention: colchicine 0.5 mg/day plus usual care vs. usual care alone; primary analysis by intention-to-treat.

Main Results:

  • The primary outcome is the time to the first recurrent ischaemic stroke, myocardial infarction, cardiac arrest, or hospitalization for unstable angina.
  • Data collection and follow-up are ongoing, with a median follow-up of 36 months anticipated.

Conclusions:

  • The CONVINCE trial aims to provide high-quality randomized data on colchicine's efficacy and safety.
  • Results will inform the use of anti-inflammatory therapy with colchicine for secondary stroke prevention.
Keywords:
Ischaemic strokecolchicineinflammationrandomised controlled trial

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