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

作者：Arturo Renú, Patricia de la Riva, Raquel Delgado‐Mederos, Laura Dorado, María Dolores Fernández-Couto, Maria Herrera-Isasi, Nicolás López Hernández, A. Morales, Lluís Morales‐Caba, Pol Camps‐Renom, Alba Singla, Mikel Terceño, Pedro Vega, Sergio Amaro, Jordi Blasco, Carlos Laredo, Enrique C. Leira, Laura Oleaga, Joaquı́n Serena, Xabier Urra, Mariano Werner, Francisco Hernández‐Fernández, Joan Valls, Juan F. Arenillas, Maria del Mar Freijo, Natàlia Pérez de la Ossa, Luís San Román, Ferràn Torres, Mar Castellanos, Antonio Dávalos, Ángel Chamorro · 发表于：Stroke and Vascular Neurology · 年份：2025 · DOI：10.1136/svn-2025-004279 · 被引用次数：3 · 研究领域：Acute Ischemic Stroke Management、Venous Thromboembolism Diagnosis and Management、Cerebrovascular and Carotid Artery Diseases

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 ...