Thrombolysis Treatment in Patients Who Are Awake and Have an Unknown Duration of Stroke Receiving Effective and Safe Treatment or Who Are Futile and At Risk: A Study-Based SITS

Background & Objective: 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.Materials & Methods: 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. Results: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 0-1: 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. Conclusion: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.