@Article{duepublico_mods_00075729,
  author = 	{Kelly, Peter
		and Weimar, Christian
		and Lemmens, Robin
		and Murphy, Sean
		and Purroy, Francisco
		and Arsovska, Anita
		and Bornstein, Natan M.
		and Czlonkowska, Anna
		and Fischer, Urs
		and Fonseca, Ana Catarina
		and Forbes, John
		and Hill, Michael D.
		and Jatuzis, Dalius
		and K{\~o}rv, Janika
		and Kruuse, Christina
		and Mikulik, Robert
		and Nederkoorn, Paul J.
		and O'Donnell, Martin
		and Sandercock, Peter
		and Tanne, David
		and Tsivgoulis, Georgios
		and Walsh, Cathal
		and Williams, David
		and Zedde, Marialuisa
		and Price, Christopher I.},
  title = 	{Colchicine for prevention of vascular inflammation in Non-CardioEmbolic stroke (CONVINCE): study protocol for a randomised controlled trial},
  year = 	{2021},
  month = 	{Jun},
  day = 	{18},
  keywords = 	{Ischaemic stroke; inflammation; colchicine; randomised controlled trial},
  abstract = 	{Background: 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. Design: 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{\thinspace}mg/day and usual care versus usual care alone (antiplatelet, lipid-lowering, antihypertensive treatment, lifestyle advice). Included patients are at least 40{\thinspace}years, with non-severe ischaemic stroke (modified Rankin score ≤3) or high-risk TIA (ABCD2{\thinspace}>{\thinspace}3, or positive DWI, or cranio-cervical artery stenosis) within 72{\thinspace}hours-28{\thinspace}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{\thinspace}months. The primary analysis will be by intention-to-treat. Outcome: The primary outcome is time to first recurrent ischaemic stroke, myocardial infarction, cardiac arrest, or hospitalisation with unstable angina (non-fatal or fatal). Summary: CONVINCE will provide high-quality randomised data on the efficacy and safety of anti-inflammatory therapy with colchicine for secondary prevention after stroke. Schedule First-patient first-visit was December 2016. Recruitment to complete in 2021, follow-up to complete in 2023.},
  note = 	{Dieser Beitrag ist mit Zustimmung des Rechteinhabers aufgrund einer (DFG-gef{\"o}rderten) Allianz- bzw. Nationallizenz frei zug{\"a}nglich.
<hr />This publication is with permission of the rights owner freely accessible due to an Alliance licence and a national licence (funded by the DFG, German Research Foundation) respectively.},
  note = 	{<p>Kelly P, Weimar C, Lemmens R, et al. Colchicine for prevention of vascular inflammation in Non-CardioEmbolic stroke (CONVINCE) -- study protocol for a randomised controlled trial. <em>European Stroke Journal</em>. 2021;6(2):222-228. doi:<a href="https://doi.org/10.1177/2396987320972566">10.1177/2396987320972566</a></p>

<p>First published online June 18, 2021</p>},
  note = 	{Version of Record / Verlagsversion},
  note = 	{deepgreen / SAGE},
  doi = 	{10.1177/2396987320972566},
  url = 	{https://duepublico2.uni-due.de/receive/duepublico_mods_00075729},
  url = 	{https://doi.org/10.1177/2396987320972566},
  file = 	{:https://duepublico2.uni-due.de/servlets/MCRFileNodeServlet/duepublico_derivate_00075465/European_Stroke_Journal_2021_6_222-228.pdf:PDF},
  language = 	{en}
}