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Publications

Journal Article Ahead of print

PubMed: 41339082 DOI: 10.1136/svn-2025-004279

Chemical Optimization of Cerebral Embolectomy 2 (CHOICE 2) trial: study protocol.

Stroke Vasc Neurol

Authors: Arturo Renú, Patricia de la Riva, Raquel Delgado-Mederos, Laura Dorado, Maria Dolores Fernandez-Couto, Maria Herrera-Isasi, Nicolás López Hernández, Ana Morales, Lluis Morales-Caba, Pol Camps-Renom, Alba Singla, Mikel Terceño, Pedro Vega, Sergio Amaro, Jordi Blasco, Carlos Laredo, Enrique C Leira, Laura Oleaga, Joaquin Serena, Xabier Urra, Mariano Werner, Francisco Hernández Fernández, Joan Valls, Juan Francisco Arenillas Lara, Maria Del Mar Freijo, Natalia Pérez de la Ossa, Luis San Roman, Ferran Torres, Mar Castellanos, Antonio Davalos, Angel Chamorro

Affiliations

  • Comprehensive Stroke Center, Hospital Clinic de Barcelona, Barcelona, Barcelona, Spain.
  • Fundació de Recerca Clínic Barcelona-Institut d'Investigacions Biomèdiques August Pi i Sunyer (FRCB-IDIBAPS), August Pi i Sunyer Institute of Biomedical Research, Barcelona, Barcelona, Spain.
  • Neurology, Donostia Ospitalea, San Sebastián, Basque Country, Spain.
  • Neurology, Son Espases University Hospital, Palma Mallorca, Balearic Island, Spain.
  • Department of Neurology, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.
  • Neurology, Complexo Hospitalario Universitario A Coruña, A Coruña, Spain.
  • Complejo Hospitalario de Navarra, Pamplona, Navarre, Spain.
  • Neurology, Dr Balmis General University Hospital, Alicante, Valencian Community, Spain.
  • Neurology, Virgen de la Arrixaca University Hospital, El Palmar, Región de Murcia, Spain.
  • Interventional Neuroradiology, La Fe University and Polytechnic Hospital, Valencia, Spain.
  • Neurology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
  • Avania Europe-Barcelona, Barcelona, Spain.
  • Neurology, Hospital Universitari de Girona Doctor Josep Trueta Servei de Neurologia, Girona, Girona, Spain.
  • Radiology, Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain.
  • Neurointerventional Department, Hospital Clinic de Barcelona Centre de Diagnostic Biomedic, Barcelona, Spain.
  • Magnetic Resonance Imaging Core Facility, August Pi i Sunyer Institute of Biomedical Research, Barcelona, Spain.
  • Neurology, University of Iowa Health Care, Iowa City, Iowa, USA.
  • Radiology, Hospital Clinic de Barcelona Centre de Diagnostic per la Imatge Clinic, Barcelona, Spain.
  • Neurology, Doctor Josep Trueta University Hospital of Girona, Girona, Spain.
  • Neurology, Complejo Hospitalario Universitario de Albacete, Albacete, Castilla-La Mancha, Spain.
  • Biostatistics and Epidemiology Unit, Autonomous University of Barcelona, Barcelona, Spain.
  • Neurology, Hospital Clinico Universitario de Valladolid, Valladolid, Spain.
  • Neurology, Cruces University Hospital, Barakaldo, Basque Country, Spain.
  • Neurology, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.
  • Medical Statistics Core Facility, Clinical Pharmacology Service, Institut d'Investigacions Biomediques August Pi i Sunyer, Barcelona, Spain.
  • Biostatistics Unit, Faculty of Medicine, Autonomous University of Barcelona, Barcelona, Spain.
  • Neuroscience, Autonomous University of Barcelona, Barcelona, Spain.
  • Comprehensive Stroke Center, Hospital Clinic de Barcelona, Barcelona, Barcelona, Spain.

Abstract

RATIONALE

The 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.

AIM

The 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 ESTIMATES

A 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 DESIGN

Multicentre, 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 OUTCOMES

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.

DISCUSSION

This 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.

MeSH

Embolectomy, Stroke, Tissue Plasminogen Activator, Reperfusion