en Clinical Medicine Clinical Medicine مقاله پژوهشی Original Research Article <p style="text-align: justify;"><span style="font-size:16px;"><span style="font-family:Times New Roman;"><span style="line-height:150%"><b>Background:</b> Stroke is a leading cause of death worldwide, with approximately 800,000 new cases and 140,000 deaths annually in the United States. Intravenous tissue plasminogen activator (IV tPA) is the standard treatment for acute ischemic stroke (AIS) within a 4.5-hour window. Wake-up stroke (WUS), where the exact onset time is unknown, poses challenges for tPA treatment because of its uncertain timing. This study evaluated the efficacy and safety of IV tPA in WUS patients, with a focus on clinical outcomes and adverse effects.</span><br> <span style="line-height:150%"><b>Methods:</b> This single-center, open-label clinical trial was conducted at the Vali-e-Asr Hospital Stroke Care Unit, Zanjan, Iran. A total of 107 patients with WUS were enrolled and divided into two groups: 53 who received IV tPA and 54 who did not receive thrombolysis. The inclusion criteria included acute neurological symptoms consistent with stroke upon waking and presentation within four hours of symptom onset. The exclusion criteria included various factors, such as intracranial hemorrhage, contraindications to MRI, severe comorbidities, and recent use of anticoagulants. Patient evaluations included NIHSS scores at admission and also at discharge, mRS scores at discharge and three months after stroke, and imaging with MRI and CT. Descriptive statistics, nonparametric tests, and regression analyses were used for data analysis.</span><br> <span style="line-height:150%"><b>Results:</b> The tPA group had significantly lower discharge NIHSS scores (4.51 vs. 6.98, p=0.006) and lower in-hospital mortality rates (3.8% vs. 22.2%, p=0.008). At three months, the tPA group had a greater proportion of favorable mRS scores (mRS 0&ndash;1: 60.4% vs. 11.1%, p<0.001) and lower total mortality (6 vs. 17 deaths, p=0.011). No significant differences in adverse effects were observed for patients over 80 years old.</span><br> <span style="line-height:150%"><b>Conclusions:</b> Compared with no treatment, IV tPA treatment in WUS patients was associated with improved clinical outcomes and reduced mortality without an increased risk of adverse effects. These findings support the consideration of tPA for WUS within the specified treatment window.</span></span></span></p> Ischemic Stroke, Wake-up Strokes, Tissue Plasminogen Activator, Treatment Outcome, Safety 28 38 http://journal.zums.ac.ir/browse.php?a_code=A-10-6954-1&slc_lang=en&sid=1 Abdoreza Ghoreishi ar.ghoreishy@gmail.com 5200319475328460082809 5200319475328460082809 No Stroke Research Group, Head of Stroke Care Unit, Department of Neurology, Vali-e-Asr Hospital, School of Medicine, Zanjan University of Medical Science, Zanjan, Iran Hamideh Nasiri hnasiri.med@gmail.com 5200319475328460082810 0009-0002-2853-2298 No Student Research Committee, Department of Neurology, School of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran Fatemeh Karami Zarandi f_karami2011@yahoo.com 5200319475328460082811 5200319475328460082811 No School of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran Kaveh Hadiloo kaveh.hadiloo@gmail.com 5200319475328460082812 5200319475328460082812 Yes Student Research Committee, Department of Neurology, School of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran