Background Stroke is the fourth leading cause of mortality and a major cause of long-term disability in the USA. IV tPA remains the only FDA-approved treatment for AIS. However, it is only approved when the time of onset is known to be <3 h. Approximately 25% of ischemic stroke patients awaken with stroke symptoms. This is called a Wake Up Stroke (WUS). The purpose of this study is to determine if WUS patients with a proof of salvageable penumbra on CT perfusion (CTP) will benefit from IV thrombolysis therapy or endovascular intervention.
Methods This study is a single center, randomized, single-blinded and prospective study to compare between medical therapy and interventions in patients with WUS. Ninety patients with wake up ischemic stroke and considerable salvageable tissue on perfusion studies (defined as TTP >8 s and volume loss <20% of the size of the penumbra) will be randomized into one of three prospective groups: (1) Best medical therapy (standard of care with anti-platelets and statins), (2) Intravenous thrombolysis (total dose of 0.9 mg/kg) and (3) Intra-arterial intervention (IA t-PA and/or MERCI device and/or PENUMBRA device). The Choice of appropriate endovascular therapy will be decided by an experienced endovascular surgeon.
Statistical analysis This is an ongoing study. Efficacy end points will be assessed in the intention-to-treat analysis. The primary end point; modified Rankin Scale at 90 days (mRs-90 days) ≤2, will be compared among the different subgroups denoted previously by χ2 distribution analysis using the SAS program (SAS V.9.1 Institute INC.). A comparison of NIHSS means among the three groups would also be performed at 24 h post ER presentation and at discharge. Initially One-Way Analysis of Variance (ANOVA) will be carried out. If the ANOVA analysis provides us with statistically significant results suggesting significant difference among the three arms, then Binary comparisons among the groups using Tukey multiple means comparison procedure will be performed. Using the means will be justified in our study since we aim to have a sample size of 90 subjects. Symptomatic intracranial hemorrhage will also be compared among the three groups.
Competing interests T Kass-Hout: Genentech. O Kass-Hout: None. M Mokin: None. M Al Masry: None. E Nourollahzadeh: None. A Siddiqui: NINDS 1R01NS064592-01A1, University at Buffalo. Shurtleff, Inc, Concentric Medical, ev3/Covidien Vascular Therapies, GuidePoint Global Consulting, Penumbra. Codman & Shurtleff, Inc, Genentech. Hotspur, Intratech Medical, StimSox, Valor Medical. Abbott Vascular, American Association of Neurological Surgeons, Neocure Group LLC, an Emergency Medicine Conference. E Levy: Codman & Shurtleff, Inc, ev3/Covidien Vascular Therapies, Boston Scientific. TheraSyn Sensors. Medical Ltd., Mynx/Access Closure. Boston Scientific. K Synder: Toshiba and ev3.
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