Journal article
Chemical Optimization of Cerebral Embolectomy 2 (CHOICE 2) trial: study protocol
Stroke and vascular neurology
12/03/2025
DOI: 10.1136/svn-2025-004279
PMID: 41339082
Abstract
RationaleThe potential value of rescue intra-arterial thrombolysis in patients with large vessel occlusion (LVO) stroke treated with mechanical thrombectomy (MT) remains to be validated in randomised trials.AimThe Chemical Optimization of Cerebral Embolectomy 2 (CHOICE 2) trial is designed to confirm whether adjunctive intra-arterial alteplase, administered after successful MT, improves clinical outcomes in patients with LVO stroke.Sample size estimatesA total of 440 patients (220 per group) randomised in a 1:1 ratio to receive intra-arterial thrombolysis or not intra-arterial thrombolysis provides 80% statistical power to detect a 14% absolute benefit in the primary endpoint (the proportion of patients achieving modified Rankin Scale (mRS) 0–1 at 90 days), assuming a rate of 40% in the control group, a 5% two-sided type I error. The sample size also provides >95% power for detecting an 18% absolute benefit in secondary imaging endpoints, assuming a 58% rate in the control group.Methods and designMulticentre, randomised, open, blinded end-point assessment phase III trial. Eligible patients are adults (≥18 years) with symptomatic LVO who undergo MT with successful or complete reperfusion at end of the procedure. Patients in the intervention group will receive a 15 min intra-arterial infusion of alteplase (1.0 mg/mL, maximum dose 20 mg).Study outcome(s)The primary outcome is the proportion of patients achieving excellent functional outcome (mRS 0–1) at 90 days. Key secondary outcomes are the presence of hypoperfusion on brain CT perfusion at 36±24 hours post randomisation, infarct expansion, Barthel Index and quality of life. Mortality and symptomatic intracerebral haemorrhage will also be evaluated.DiscussionThis trial will provide evidence whether rescue intra-arterial thrombolysis improves clinical outcome in patients with LVO stroke who achieve successful or complete angiographic reperfusion following MT.
Details
- Title: Subtitle
- Chemical Optimization of Cerebral Embolectomy 2 (CHOICE 2) trial: study protocol
- Creators
- Arturo Renú - Hospital Clínic de BarcelonaPatricia de la Riva - Donostiako Unibertsitate OspitaleaRaquel Delgado-Mederos - Hospital Universitario Son EspasesLaura Dorado - Hospital Universitari Germans Trias i PujolMaria Dolores Fernandez-Couto - Complexo Hospitalario Universitario A CoruñaMaria Herrera-Isasi - Complejo Hospitalario de NavarraNicolás López Hernández - Hospital General Universitario de Alicante Doctor BalmisAna Morales - Hospital Universitario Virgen de la ArrixacaLluis Morales-Caba - Hospital Universitari i Politècnic La FePol Camps-Renom - Hospital de Sant PauAlba Singla - RMIT EuropeMikel Terceño - Hospital Universitari de Girona Doctor Josep TruetaPedro Vega - Central University Hospital of AsturiasSergio Amaro - Consorci Institut D'Investigacions Biomediques August Pi I SunyerJordi Blasco - Hospital Clínic de BarcelonaCarlos Laredo - Biomedical Research InstituteEnrique C Leira - University of IowaLaura Oleaga - Hospital Clínic de BarcelonaJoaquin Serena - Hospital Universitari de Girona Doctor Josep TruetaXabier Urra - Hospital Clínic de BarcelonaMariano Werner - Hospital Clínic de BarcelonaFrancisco Hernández Fernández - Complejo Hospitalario Universitario de AlbaceteJoan Valls - Universitat Autònoma de BarcelonaJuan Francisco Arenillas Lara - Hospital Clínico Universitario de ValladolidMaria del Mar Freijo - Hospital de CrucesNatalia Pérez de la Ossa - Hospital Universitari Germans Trias i PujolLuis San Roman - Hospital Clínic de BarcelonaFerran Torres - Universitat Autònoma de BarcelonaMar Castellanos - Complexo Hospitalario Universitario A CoruñaAntonio Davalos - Universitat Autònoma de BarcelonaAngel Chamorro - Hospital de Nens de BarcelonaCHOICE 2 Investigators
- Resource Type
- Journal article
- Publication Details
- Stroke and vascular neurology
- DOI
- 10.1136/svn-2025-004279
- PMID
- 41339082
- NLM abbreviation
- Stroke Vasc Neurol
- ISSN
- 2059-8688
- eISSN
- 2059-8696
- Publisher
- BMJ Publishing Group Ltd
- Grant note
- ICI22/00064 / Ministry of Science, Innovation and Universities-Carlos III Health Institute RD16/0019 / Spanish Research Network on Cerebrovascular Diseases
- Language
- English
- Electronic publication date
- 12/03/2025
- Academic Unit
- Neurology; Epidemiology; Iowa Neuroscience Institute; Neurosurgery
- Record Identifier
- 9985090622702771
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