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

J 2021

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

KELLY, P., C. WEIMAR, R. LEMMENS, S. MURPHY, F. PURROY et. al.

Basic information

Original name

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

Authors

KELLY, P. (guarantor), 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 Czech Republic, belonging to the institution), P. J. NEDERKOORN, M. O DONNELL, P. SANDERCOCK, D. TANNE, G. TSIVGOULIS, C. WALSH, D. WILLIAMS, M. ZEDDE and C. I. PRICE

Edition

EUROPEAN STROKE JOURNAL, LONDON, SAGE PUBLICATIONS LTD, 2021, 2396-9873

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30210 Clinical neurology

Country of publisher

United Kingdom of Great Britain and Northern Ireland

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 5.894

RIV identification code

RIV/00216224:14110/21:00122126

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1177/2396987320972566

UT WoS

000663373100027

Keywords in English

Ischaemic stroke; inflammation; colchicine; randomised controlled trial

Abstract

V originále

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.

Citovat

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 and 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, vol. 6, No 2, p. 222-228. ISSN 2396-9873. Available from: https://dx.doi.org/10.1177/2396987320972566.

@article{1786878,
   author = {Kelly, P. and Weimar, C. and Lemmens, R. and Murphy, S. and Purroy, F. and Arsovska, A. and Bornstein, N. M. and Czlonkowska, A. and Fischer, U. and Fonseca, A. C. and Forbes, J. and Hill, M. D. and Jatuzis, D. and Korv, J. and Kruuse, C. and Mikulík, Robert and Nederkoorn, P. J. and O Donnell, M. and Sandercock, P. and Tanne, D. and Tsivgoulis, G. and Walsh, C. and Williams, D. and Zedde, M. and Price, C. I.},
   article_location = {LONDON},
   article_number = {2},
   doi = {http://dx.doi.org/10.1177/2396987320972566},
   keywords = {Ischaemic stroke; inflammation; colchicine; randomised controlled trial},
   language = {eng},
   issn = {2396-9873},
   journal = {EUROPEAN STROKE JOURNAL},
   title = {Colchicine for prevention of vascular inflammation in Non-CardioEmbolic stroke (CONVINCE) - study protocol for a randomised controlled trial},
   url = {https://journals.sagepub.com/doi/10.1177/2396987320972566},
   volume = {6},
   year = {2021}
}

TY  - JOUR
ID  - 1786878
AU  - Kelly, P. - Weimar, C. - Lemmens, R. - Murphy, S. - Purroy, F. - Arsovska, A. - Bornstein, N. M. - Czlonkowska, A. - Fischer, U. - Fonseca, A. C. - Forbes, J. - Hill, M. D. - Jatuzis, D. - Korv, J. - Kruuse, C. - Mikulík, Robert - Nederkoorn, P. J. - O Donnell, M. - Sandercock, P. - Tanne, D. - Tsivgoulis, G. - Walsh, C. - Williams, D. - Zedde, M. - Price, C. I.
PY  - 2021
TI  - Colchicine for prevention of vascular inflammation in Non-CardioEmbolic stroke (CONVINCE) - study protocol for a randomised controlled trial
JF  - EUROPEAN STROKE JOURNAL
VL  - 6
IS  - 2
SP  - 222-228
EP  - 222-228
PB  - SAGE PUBLICATIONS LTD
SN  - 23969873
KW  - Ischaemic stroke
KW  - inflammation
KW  - colchicine
KW  - randomised controlled trial
UR  - https://journals.sagepub.com/doi/10.1177/2396987320972566
N2  - 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.
ER  -

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 and C. I. PRICE. Colchicine for prevention of vascular inflammation in Non-CardioEmbolic stroke (CONVINCE) - study protocol for a randomised controlled trial. \textit{EUROPEAN STROKE JOURNAL}. LONDON: SAGE PUBLICATIONS LTD, 2021, vol.~6, No~2, p.~222-228. ISSN~2396-9873. Available from: https://dx.doi.org/10.1177/2396987320972566.

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