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NAVIGATE ESUS

Official Title

Multicenter, randomized, double-blind, double-dummy, active-comparator, event-driven, superiority phase III study of secondary prevention of stroke and prevention of systemic embolism in patients with a recent Embolic Stroke of Undetermined Source (ESUS), comparing rivaroxaban 15 mg once daily with aspirin 100 mg (NAVIGATE ESUS)

Status

Ongoing

Overview

To evaluate whether rivaroxaban is superior to aspirin in reducing the risk of recurrent stroke and systemic embolic events in patients with a recent ESUS. Patients who fulfill all inclusion and none of the exclusion criteria after giving informed consent will be randomly allocated 1:1 to either rivaroxaban 15mg or aspirin 100mg orally once daily. Randomization will be stratified by country and age <60 and ≥60 years. No more than 10% of the total patient population will be randomized into the age group <60 years. The study is event-driven and thus, all patients will be 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.

Study Design

Multicenter, randomized, double-blind, double-dummy, active-comparator, event-driven, superiority phase III study

Primary Endpoint

The primary efficacy objective is:
• 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 is:
• 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 is to document the incidence of clinically relevant bleeding

Number of Patients

7000

Number of Sites

515

Number of Countries

31

Study Period

2014–2018

Principal Investigator

Robert Hart, Stuart Connolly

Program Manager

Ellison Themeles

Research Coordinator

Suzanne Bajkor

Collaborators

Bayer