Intravenous Tenecteplase for Acute Ischemic Stroke Within 4.5-24 Hours of Onset (ROSE-TNK): A Phase 2, Randomized, Multicenter Study.

"Conflicts of interest: The authors have no financial conflicts of interest."

"Funding statement"

"Given that this was an exploratory trial, the sample size was not formally calculated and was set at 80 (40 patients per group) according to the recommendations of the Steering Committee. Statistical analyses were performed based on the intention-to-treat principle. Measurement data are represented by mean and standard deviation, if not skewed, or median and interquartile range, if skewed. Categorical data are presented as numbers (percentages). Primary analyses of the primary and secondary endpoints were not performed. The rank sum test or t-test was used for the unadjusted analysis of the measurement data, whereas the chi-square test was used for the unadjusted analysis of the categorical data. Covariate-adjusted binary logistic regression analyses were performed for all outcomes, adjusting for six prespecified prognostic factors including age, sex, systolic blood pressure, ischemic stroke, NIHSS score at presentation, and time from onset to randomization. Binary logistic regression was performed for the adjusted analysis of the primary and secondary outcomes, including favorable functional outcomes at 90 days, occurrence of ENI within 24 hours, proportion of sICH within 48 hours, proportion of parenchymal hemorrhage within 48 hours, any bleeding events within 7 days, and mortality within 14 days. An odds ratio (OR) with 95% confidence interval (CI) was calculated. The 90-day mRS score was compared using ordinal logistic regression, which was presented as an OR with 95% CI. A generalized linear model was used to compare the changes in NIHSS scores from baseline to 24 hours and 7 days after randomization, and an absolute difference with a 95% CI was calculated between the two groups. Descriptive statistics of the proportions were used as the safety endpoints. Statistical tests were considered significant when the two-sided P-value was less than 0.05. The SPSS software (version 20; IBM Corp., Armonk, NY, USA) was used for the statistical tests. This trial was registered at ClinicalTrials.gov (NCT04752631)."