Clinical trial protocol outlines statistical methods for evaluating pre-hospital blood pressure reduction in acute stroke, ensuring rigorous assessment of 90-day functional recovery.
INTERACT4 aims to determine the effectiveness of pre-hospital administered blood pressure lowering treatment initiated in an ambulance setting on functional outcome at 90 days in patients who have elevated BP after suffering an acute stroke. This statistical analysis plan pre-specifies the method of analysis for every outcome and key variable collected in the trial. The primary analysis will consist in an ordinal logistic regression conducted in all patients with a confirmed acute cerebrovascular disease event. The statistical analysis plan also includes planned sensitivity analyses including covariate adjustments, missing data imputations and subgroup analyses.
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Billot et al. (2023) studied this question.
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