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Characterization of Patients with Embolic Strokes of Undetermined Source in the NAVIGATE ESUS Randomized Trial
dc.creator | Kasner S.E., Lavados P., Sharma M., Wang Y., Wang Y., Dávalos A., Shamalov N., Cunha L., Lindgren A., Mikulik R., Arauz A., Lang W., Czlonkowska A., Eckstein J., Gagliardi R., Amarenco P., Ameriso S.F., Tatlisumak T., Veltkamp R., Hankey G.J., Toni D.S., Bereczki D., Uchiyama S., Ntaios G., Yoon B.-W., Brouns R., DeVries Basson M.M., Endres M., Muir K., Bornstein N., Ozturk S., O'Donnell M., Mundl H., Pater C., Weitz J., Peacock W.F., Swaminathan B., Kirsch B., Berkowitz S.D., Peters G., Pare G., Themeles E., Shoamanesh A., Connolly S.J., Hart R.G., NAVIGATE ESUS Steering Committee and Investigators | en |
dc.date.accessioned | 2023-01-31T08:33:01Z | |
dc.date.available | 2023-01-31T08:33:01Z | |
dc.date.issued | 2018 | |
dc.identifier | 10.1016/j.jstrokecerebrovasdis.2018.01.027 | |
dc.identifier.issn | 10523057 | |
dc.identifier.uri | http://hdl.handle.net/11615/74575 | |
dc.description.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 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. © 2018 National Stroke Association | en |
dc.language.iso | en | en |
dc.source | Journal of Stroke and Cerebrovascular Diseases | en |
dc.source.uri | https://www.scopus.com/inward/record.uri?eid=2-s2.0-85042946778&doi=10.1016%2fj.jstrokecerebrovasdis.2018.01.027&partnerID=40&md5=42d01ed4ea67515db127a5b7dc010619 | |
dc.subject | acetylsalicylic acid | en |
dc.subject | rivaroxaban | en |
dc.subject | acetylsalicylic acid | en |
dc.subject | antithrombocytic agent | en |
dc.subject | blood clotting factor 10a inhibitor | en |
dc.subject | fibrinolytic agent | en |
dc.subject | rivaroxaban | en |
dc.subject | adult | en |
dc.subject | aged | en |
dc.subject | Article | en |
dc.subject | brain embolism | en |
dc.subject | brain infarction | en |
dc.subject | cerebrovascular accident | en |
dc.subject | cohort analysis | en |
dc.subject | controlled study | en |
dc.subject | coronary artery disease | en |
dc.subject | diabetes mellitus | en |
dc.subject | double blind procedure | en |
dc.subject | drug efficacy | en |
dc.subject | drug safety | en |
dc.subject | female | en |
dc.subject | human | en |
dc.subject | hypertension | en |
dc.subject | major clinical study | en |
dc.subject | male | en |
dc.subject | malignant neoplasm | en |
dc.subject | middle aged | en |
dc.subject | phase 3 clinical trial | en |
dc.subject | priority journal | en |
dc.subject | race | en |
dc.subject | randomized controlled trial | en |
dc.subject | transient ischemic attack | en |
dc.subject | age | en |
dc.subject | ancestry group | en |
dc.subject | brain embolism | en |
dc.subject | cerebrovascular accident | en |
dc.subject | clinical trial | en |
dc.subject | comorbidity | en |
dc.subject | comparative study | en |
dc.subject | multicenter study | en |
dc.subject | risk factor | en |
dc.subject | sex factor | en |
dc.subject | transient ischemic attack | en |
dc.subject | treatment outcome | en |
dc.subject | very elderly | en |
dc.subject | Age Factors | en |
dc.subject | Aged | en |
dc.subject | Aged, 80 and over | en |
dc.subject | Aspirin | en |
dc.subject | Comorbidity | en |
dc.subject | Continental Population Groups | en |
dc.subject | Double-Blind Method | en |
dc.subject | Factor Xa Inhibitors | en |
dc.subject | Female | en |
dc.subject | Fibrinolytic Agents | en |
dc.subject | Humans | en |
dc.subject | Intracranial Embolism | en |
dc.subject | Ischemic Attack, Transient | en |
dc.subject | Male | en |
dc.subject | Middle Aged | en |
dc.subject | Platelet Aggregation Inhibitors | en |
dc.subject | Risk Factors | en |
dc.subject | Rivaroxaban | en |
dc.subject | Sex Factors | en |
dc.subject | Stroke | en |
dc.subject | Treatment Outcome | en |
dc.subject | W.B. Saunders | en |
dc.title | Characterization of Patients with Embolic Strokes of Undetermined Source in the NAVIGATE ESUS Randomized Trial | en |
dc.type | journalArticle | en |
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