Colchicine for prevention of vascular inflammation in Non-CardioEmbolic stroke (CONVINCE) – study protocol for a randomised controlled trial
Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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 follow-up will be 36 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.
Originalsprog | Engelsk |
---|---|
Tidsskrift | European Stroke Journal |
Vol/bind | 6 |
Udgave nummer | 2 |
Sider (fra-til) | 222-228 |
Antal sider | 7 |
ISSN | 2396-9873 |
DOI | |
Status | Udgivet - 2021 |
Bibliografisk note
Funding Information:
The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: All authors have collaborated on successful funding applications from HRB Ireland for CONVINCE. RL has received a grant from FWO Belgium and CW from DFG Germany for CONVINCE (non-overlapping awards). PK has received funding from the Irish Heart Foundation which supports CONVINCE.
Funding Information:
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work is supported by Health Research Board Ireland awards CTN-2014–014, DIFA-2018–006, DIFA -2017–028, OLF-2018–1, Deutsche Forschungsgesellschaft (DFG) award WE 2858/5 -1 – AOBJ: 661984, and Fonds Wetenschappelijk Onderzoek (FWO) award: T001719N, and by the Irish Heart Foundation. RL is a senior clinical investigator of FWO Flanders.
Publisher Copyright:
© European Stroke Organisation 2020.
Links
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8370082/pdf/10.1177_2396987320972566.pdf
Forlagets udgivne version
ID: 280285164