completed

The objective of Navigate ESUS, a multicenter, randomized, double-blind, double-dummy, active-comparator, event-driven, superiority phase III study, was to evaluate whether rivaroxaban is superior to aspirin in reducing the risk of recurrent stroke and systemic embolic events in patients with a recent embolic stroke of undetermined source (ESUS).

Patients who fulfilled all inclusion, and none of the exclusion criteria after giving informed consent, were randomly allocated 1:1 to either rivaroxaban 15mg or aspirin 100mg orally once daily. Randomization was stratified by country and age <60 and ≥60 years. No more than 10% of the total patient population was randomized into the age group <60 years.

The study was event-driven and thus all patients were treated (or followed-up in case of premature discontinuation of study medication) until the required approximately 450 confirmed primary efficacy outcomes are expected to have occurred.

The primary efficacy objective was to evaluate whether rivaroxaban is superior to aspirin in reducing the risk of recurrent stroke and systemic embolism in patients with a recent ESUS

The secondary efficacy objective was to evaluate whether rivaroxaban is superior to aspirin in reducing cerebrovascular events, cardiovascular events, and mortality in patients with a recent ESUS

The safety objective was to document the incidence of clinically relevant bleeding.

Download Presentation PDF
Study Type

Interventional - Drug

Study Design

Multicenter, randomized, double-blind, double-dummy

NO. of Countries

32

NO. of Sites

480

NO. of Participants

7214

Study Period

2014-2017

Sponsor

Bayer

Robert Hart discusses Navigate ESUS at ESC 2018

Back To Top