Rivaroxaban Versus Aspirin in Secondary Prevention of Stroke and Prevention of Systemic Embolism in Patients With Recent Embolic Stroke of Undetermined Source (ESUS)

Summary

This is a study in patients who recently had a brain attack (stroke) and in whom no clear cause of the stroke could be identified. These strokes are likely due to a blood clot and therefore, can be called embolic stroke of undetermined source. The abbreviation is ESUS. The study will compare 2 blood thinners. Patients will be randomly assigned to either Rivaroxaban 15 mg or Aspirin 100 mg and the study is intended to show, if patients given rivaroxaban have fewer blood clots in the brain (stroke) or in other blood vessels.

Conditions

• Stroke

Interventions

DRUG

Rivaroxaban (Xarelto, BAY59-7939)

15 mg, once daily, orally, tablet

DRUG

Acetylsalicylic acid (Aspirin, BAY1019036)

100 mg, once daily, orally, tablet

OTHER

Rivaroxaban-Placebo

Matching placebo, once daily, orally, tablet

OTHER

Aspirin-Placebo

Matching placebo, once daily, orally, tablet

Sponsors & Collaborators

• Janssen Research & Development, LLC

  collaborator INDUSTRY

• Population Health Research Institute

  collaborator OTHER

• Bayer

  lead INDUSTRY

Principal Investigators

• Bayer Study Director · Bayer

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-12-23

Primary Completion

2018-02-15

Completion

2018-02-15

FDA Drug

Yes

Countries

• United States
• Argentina
• Australia
• Austria
• Belgium
• Brazil
• Canada
• Chile
• China
• Czechia
• Denmark
• Finland
• France
• Germany
• Greece
• Hungary
• Ireland
• Israel
• Italy
• Japan
• Mexico
• Poland
• Portugal
• Russia
• South Africa
• South Korea
• Spain
• Sweden
• Switzerland
• Turkey (Türkiye)
• United Kingdom

Study Locations