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 had more hypertension, coronary disease, and cancer. Strokes in older subjects were more frequently cortical and accompanied by radiographic evidence of prior infarction. Women comprised 38% of participants and were older than men. Patients from East Asia were oldest whereas those from Latin America were youngest. Patients in the Americas more frequently were on aspirin prior to the qualifying stroke. Acute cortical infarction was more common in the United States, Canada, and Western Europe, whereas prior radiographic infarctions were most common in East Asia. Approximately forty-five percent of subjects were enrolled within 30 days of the qualifying stroke, with earliest enrollments in Asia and Eastern Europe. CONCLUSIONS: NAVIGATE-ESUS is the largest randomized trial comparing antithrombotic strategies for secondary stroke prevention in patients with ESUS. The study population encompasses a broad array of patients across multiple continents and these subgroups provide ample opportunities for future research.

Bayer Healthcare Pharmaceuticals Parsipanny New Jersey USA

Bayer Pharma AG Berlin Germany

Bayer Pharma AG Wuppertal Germany

Bayer Vital Leverkusen Germany

Baylor College of Medicine Houston USA

Centro Hospitalar e Universitário de Coimbra Coimbra Portugal

Clinica Alemana de Santiago Universidad del Desarrollo Universidad de Chile Santiago Chile

Departament of Neuroscencies Hospital Universitari Germans Trias i Pujol Barcelona Spain

Department of Clinical Sciences Department of Neurology and Rehabilitation Medicine Skane University Hospital Lund University Lund Sweden

Department of Innere Medizin Universitätsspital Basel Basel Switzerland

Department of Medicine Population Health Research Institute McMaster University Hamilton Health Sciences Hamilton Canada

Department of Medicine University of Thessaly Larissa Greece

Department of Neurology and Psychiatry Sapienza University of Rome Rome Italy

Department of Neurology Beijing Tiantan Hospital Capital Medical University Beijing China

Department of Neurology Bichat Hospital Paris France

Department of Neurology Helsinki University Central Hospital Helsinki Finland

Department of Neurology Institute of Psychiatry and Neurology Medical University of Warsaw Warsaw Poland

Department of Neurology Selcuk University Konya Turkey

Department of Neurology Semmelweis University Budapest Hungary

Department of Neurology Seoul National University Hospital Seoul Korea

Department of Neurology University of Pennsylvania Philadelphia United States

Hospital St John of God Medical Faculty Sigmund Freud University Vienna Austria

Imperial College London London United Kingdom

Institute for Neurological Research Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia Buenos Aires Argentina

Institute of Neuroscience and Psychology University of Glasgow Queen Elizabeth University Hospital Glasgow United Kingdom

Instituto Nacional de Neurologia y Neurocirugia Mexico D F Mexico

International Clinical Research Center and Neurology Department St Anne's University Hospital Brno Czech Republic

Irmandade da Santa Casa de Misericórdia de São Paulo Sao Paulo Brazil

Janssen Research and Development LLC Spring House United States

Klinik und Hochschulambulanz für Neurologie Center for Stroke Research Berlin Charité Universitätsmedizin Berlin Germany

National University of Ireland Galway Ireland

Pirogov Russian National Research Medical University Moscow Russia

Population Health Research Institute Hamilton Canada

Population Health Research Institute McMaster University Hamilton Health Sciences Hamilton Canada

Sanno Hospital and Sanno Medical Center Tokyo Japan

School of Medicine and Pharmacology University of Western Australia Sir Charles Gairdner Hospital Perth Australia

Shaare Zedek Medical Center Jerusalem Israel

Thrombosis and Atherosclerosis Research Institute McMaster University Hamilton Canada

Tiervlei Trial Centre Cape Town South Africa

Universitair Ziekenhuis Brussel Brussels Belgium

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