Characterization of Patients with Embolic Strokes of Undetermined Source in the NAVIGATE ESUS Randomized Trial.

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 a randomized phase-III trial comparing rivaroxaban versus aspirin in patients with recent ESUS.

Aims

We aimed to describe the baseline characteristics of this large ESUS cohort to explore relationships among key subgroups.

Methods

We enrolled 7213 patients at 459 sites in 31 countries. Prespecified subgroups for primary safety and efficacy analyses included age, sex, race, global region, stroke or transient ischemic attack prior to qualifying event, time to randomization, hypertension, and diabetes mellitus.

Results

Mean age was 66.9 ± 9.8 years; 24% were under 60 years. Older patients ha

SUBMITTER: Kasner SE 

PROVIDER: S-EPMC6701183 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature