Abstract
Background: The New Approach riVaroxaban Inhibition of Factor Xa in a Global trial vs. ASA to prevenT Embolism in Embolic Stroke of Undetermined Source (NAVIGATE-ESUS) trial is an international randomized phase III trial comparing rivaroxaban versus aspirin in patients with recent ESUS. While these patients share the common stroke mechanism of ESUS, the underlying potential embolic sources vary, and therefore a detailed description of the baseline characteristics across key subgroups is essential. Methods: A total of 7000 patients were enrolled and the study will continue until at least 450 primary events have occurred. The primary efficacy outcome is time to recurrent stroke or systemic embolism. Baseline characteristics collected in the trial include demographic features, medical history, qualifying stroke information, baseline functional and cognitive status, and the results of diagnostic testing. Pre-specified subgroups analyses for the primary safety and efficacy outcomes include: age, sex, race, global region, body mass index, weight, estimated glomerular filtration rate, stroke or TIA prior to qualifying event, time from qualifying stroke to randomization, duration of cardiac rhythm monitoring, PFO, hypertension, and diabetes mellitus. Results: Participants were recruited from 460 sites in 31 countries between December 2014 and September 2017. A summary of baseline characteristics for the initial 6271 participants (will be updated) according to prespecified age subgroups are shown in the Table. Additional subgroup comparisons will be presented. Conclusions: NAVIGATE ESUS will be the largest randomized trial comparing antithrombotic therapeutic strategies for secondary stroke prevention in patients with ESUS. The study population encompasses a wide array of patients across multiple continents with important differences according to age. The results are expected to have a global impact.
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