KELLY, P., C. WEIMAR, R. LEMMENS, S. MURPHY, F. PURROY, A. ARSOVSKA, N. M. BORNSTEIN, A. CZLONKOWSKA, U. FISCHER, A. C. FONSECA, J. FORBES, M. D. HILL, D. JATUZIS, J. KORV, C. KRUUSE, Robert MIKULÍK, P. J. NEDERKOORN, M. O DONNELL, P. SANDERCOCK, D. TANNE, G. TSIVGOULIS, C. WALSH, D. WILLIAMS, M. ZEDDE a C. I. PRICE. Colchicine for prevention of vascular inflammation in Non-CardioEmbolic stroke (CONVINCE) - study protocol for a randomised controlled trial. EUROPEAN STROKE JOURNAL. LONDON: SAGE PUBLICATIONS LTD, 2021, roč. 6, č. 2, s. 222-228. ISSN 2396-9873. Dostupné z: https://dx.doi.org/10.1177/2396987320972566.
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Základní údaje
Originální název Colchicine for prevention of vascular inflammation in Non-CardioEmbolic stroke (CONVINCE) - study protocol for a randomised controlled trial
Autoři KELLY, P. (garant), C. WEIMAR, R. LEMMENS, S. MURPHY, F. PURROY, A. ARSOVSKA, N. M. BORNSTEIN, A. CZLONKOWSKA, U. FISCHER, A. C. FONSECA, J. FORBES, M. D. HILL, D. JATUZIS, J. KORV, C. KRUUSE, Robert MIKULÍK (203 Česká republika, domácí), P. J. NEDERKOORN, M. O DONNELL, P. SANDERCOCK, D. TANNE, G. TSIVGOULIS, C. WALSH, D. WILLIAMS, M. ZEDDE a C. I. PRICE.
Vydání EUROPEAN STROKE JOURNAL, LONDON, SAGE PUBLICATIONS LTD, 2021, 2396-9873.
Další údaje
Originální jazyk angličtina
Typ výsledku Článek v odborném periodiku
Obor 30210 Clinical neurology
Stát vydavatele Velká Británie a Severní Irsko
Utajení není předmětem státního či obchodního tajemství
WWW URL
Impakt faktor Impact factor: 5.894
Kód RIV RIV/00216224:14110/21:00122126
Organizační jednotka Lékařská fakulta
Doi http://dx.doi.org/10.1177/2396987320972566
UT WoS 000663373100027
Klíčová slova anglicky Ischaemic stroke; inflammation; colchicine; randomised controlled trial
Štítky 14110127, rivok
Příznaky Mezinárodní význam, Recenzováno
Změnil Změnila: Mgr. Tereza Miškechová, učo 341652. Změněno: 19. 8. 2021 11:41.
Anotace
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 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 followup will be 36months. 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.
VytisknoutZobrazeno: 22. 8. 2024 15:33