Design of the BEST‐II Randomized Clinical Trial
نویسندگان
چکیده
Background Prior observational studies indicate that lower systolic blood pressure (SBP) after successful endovascular treatment (EVT) is associated with better functional outcomes in patients acute ischemic stroke. However, whether targeting SBP to levels below the guideline‐recommended target of ≤180 mm Hg safe and efficacious remains be determined. Methods The BEST (Blood Pressure After Endovascular Stroke Therapy)‐II trial (NCT04116112) a pragmatic, phase 2, multisite, prospective, randomized, open‐label blinded end‐point assessment designed (1) compare safety targets higher successfully EVT‐treated stroke (2) inform design estimate probability success future 3 trial. A total 120 who undergo EVT (final modified Thrombolysis Cerebral Infarction score ≥2b) for intracranial internal carotid artery or M1 M2 segment middle cerebral will randomized ≤180, <160, <140 Hg, maintained 24 hours using intravenous nicardipine as first‐line agent. We assess harm decreased post‐EVT by quantifying its linear relationship multiple primary final infarct volume on magnetic resonance imaging (or computed tomography) at 36 utility‐weighted Rankin scale 90 days. study approved Institutional Review Boards both participating institutions Data Safety Monitoring Board. Results Enrollment BEST‐II began January 2020, enrolled October 13, 2021. progressing ahead target, an anticipated enrollment completion date before 2023. Conclusions results community are treated demonstrate feasibility achieving well conducting efficacy Trial despite COVID‐19 pandemic. Clinical Registration Information NCT04116112 ( https://clinicaltrials.gov/ct2/show/NCT04116112 )
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ژورنال
عنوان ژورنال: Stroke: vascular and interventional neurology
سال: 2022
ISSN: ['2694-5746']
DOI: https://doi.org/10.1161/svin.121.000249