Evidence map›Paper›PMID 29525076›Full record

Trial reportJournal of stroke and cerebrovascular diseases : the official journal of National Stroke Association2018

Characterization of Patients with Embolic Strokes of Undetermined Source in the NAVIGATE ESUS Randomized Trial.

Scott E Kasner, Pablo Lavados, Mukul Sharma, Yongjun Wang, Yilong Wang, Antoni Dávalos, Nikolay Shamalov, Luis Cunha, Arne Lindgren, Robert Mikulik and 36 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02313909 (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), which is not on this map. Cited by 19 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 2 pooled it
6.7field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02313909 phase3terminatednot on this map

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

TypeinterventionalSponsorBayerRan2014 to 2018Enrolled7,213ConditionsStrokeArmsRivaroxaban (Xarelto, BAY59-7939), Acetylsalicylic acid (Aspirin, BAY1019036), Rivaroxaban-Placebo, Aspirin-Placebo
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 2 syntheses or guidelines pooled it, 51 citations in OpenAlex.

  1. Pooled it
  2. Antiplatelet agents and anticoagulants for hypertension.The Cochrane database of systematic reviews · 2022
    Pooled it
  3. Trial
  4. Trial
  5. Review
  6. Observational
  7. Review
  8. Article
  9. Article
  10. Review
  11. Partitioning risk factors for embolic stroke of undetermined source using exploratory factor analysis.International journal of stroke : official journal of the International Stroke Society · 2022
    Article
  12. Article
  13. Article
  14. Article
  15. Review
  16. Article
  17. Article
  18. Article
  19. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

46 authors at 20 institutions in 30 countries.

Scott E KasnerDepartment of Neurology, University of Pennsylvania, Philadelphia, United States. Electronic address: kasner@pennmedicine.upenn.edu.
Pablo LavadosClinica Alemana de Santiago, Universidad del Desarrollo, Universidad de Chile, Santiago, Chile.
Mukul SharmaDepartment of Medicine (Neurology), Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Canada.
Yongjun WangDepartment of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Yilong WangDepartment of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Antoni DávalosDepartament of Neuroscencies, Hospital Universitari Germans Trias i Pujol, Barcelona, Spain.
Nikolay ShamalovPirogov Russian National Research Medical University, Moscow, Russia.
Luis CunhaCentro Hospitalar e Universitário de Coimbra, Coimbra, Portugal.
Arne LindgrenDepartment of Clinical Sciences (Neurology), Department of Neurology and Rehabilitation Medicine, Skane University Hospital, Lund University, Lund, Sweden.
Robert MikulikInternational Clinical Research Center and Neurology Department, St. Anne's University Hospital, Brno, Czech Republic.
Antonio ArauzInstituto Nacional de Neurologia y Neurocirugia, Mexico D.F., Mexico.
Wilfried LangHospital St. John of God, Medical Faculty, Sigmund Freud University, Vienna, Austria.
Anna Czlonkowska2(nd) Department of Neurology, Institute of Psychiatry and Neurology, Medical University of Warsaw, Warsaw, Poland.
Jens EcksteinDepartment of Innere Medizin, Universitätsspital Basel, Basel, Switzerland.
Rubens GagliardiIrmandade da Santa Casa de Misericórdia de São Paulo, Sao Paulo, Brazil.
Pierre AmarencoDepartment of Neurology, Bichat Hospital, Paris, France.
Sebastián F AmerisoInstitute for Neurological Research, Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia (FLENI), Buenos Aires, Argentina.
Turgut TatlisumakDepartment of Neurology, Helsinki University Central Hospital, Helsinki, Finland.
Roland VeltkampImperial College London, London, United Kingdom.
Graeme J HankeySchool of Medicine and Pharmacology, University of Western Australia, Sir Charles Gairdner Hospital, Perth, Australia.
Danilo S ToniDepartment of Neurology and Psychiatry, "Sapienza" University of Rome, Rome, Italy.
Daniel BereczkiDepartment of Neurology, Semmelweis University, Budapest, Hungary.
Shinichiro UchiyamaSanno Hospital and Sanno Medical Center, Tokyo, Japan.
George NtaiosDepartment of Medicine, University of Thessaly, Larissa, Greece.
Byung-Woo YoonDepartment of Neurology, Seoul National University Hospital, Seoul, Korea.
Raf BrounsUniversitair Ziekenhuis Brussel, Brussels, Belgium.
M M DeVries BassonTiervlei Trial Centre, Cape Town, South Africa.
Matthias EndresKlinik und Hochschulambulanz für Neurologie, Center for Stroke Research Berlin, Charité-Universitätsmedizin, Berlin, Germany.
Keith MuirInstitute of Neuroscience and Psychology, University of Glasgow, Queen Elizabeth University Hospital, Glasgow, United Kingdom.
Natan BornsteinShaare-Zedek Medical Center, Jerusalem, Israel.
Serefnur OzturkDepartment of Neurology, Selcuk University, Konya, Turkey.
Martin O'DonnellNational University of Ireland, Galway, Ireland.
Hardi MundlBayer Pharma AG, Wuppertal, Germany.
Calin PaterBayer Vital, Leverkusen, Germany.
Jeffrey WeitzThrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, Canada.
W Frank PeacockBaylor College of Medicine, Houston, USA.
Balakumar SwaminathanPopulation Health Research Institute, Hamilton, Canada.
Bodo KirschBayer Pharma AG, Berlin, Germany.
Scott D BerkowitzBayer Healthcare Pharmaceuticals, Parsipanny, New Jersey, USA.
Gary PetersJanssen Research and Development, LLC, Spring House, United States.
Guillaume PareDepartment of Medicine, Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Canada.
Ellison ThemelesPopulation Health Research Institute, Hamilton, Canada.
Ashkan ShoamaneshDepartment of Medicine (Neurology), Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Canada.
Stuart J ConnollyDepartment of Medicine (Cardiology), Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Canada.
Robert G HartPopulation Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Canada.
NAVIGATE ESUS Steering Committee and Investigators
Population Health Research Institute · CABayer (Germany) · DECapital Medical University · CNBayer (United States) · USBaylor College of Medicine · USCape Town Science Centre · ZACharité - Universitätsmedizin Berlin · DEFundación para la Lucha contra las Enfermedades Neurológicas de la Infancia · ARHelsinki University Hospital · FIHôpital Bichat-Claude-Bernard · FRHospitais da Universidade de Coimbra · PTHospital Universitari Germans Trias i Pujol · ESImperial College London · GBInstituto Nacional de Neurología y Neurocirugía · MXIrmandade da Santa Casa de Misericórdia de São Paulo · BRJanssen (United States) · USLund University · SEMedical University of Warsaw · PLOllscoil na Gaillimhe – University of Galway · IEPirogov Russian National Research Medical University · RU

Funding

A Patient Centered Approach to Restarting Oral Anticoagulant Therapy After Major HemorrhageK23HL127227 · NHLBI · SETON HEALTHCARE · PI MILLING, TRUMAN · 2016 to 2021
$764k
NHLBI NIH HHS K23 HL127227
6 · The paper itself

Abstract

backgroundThe 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.

aimsWe aimed to describe the baseline characteristics of this large ESUS cohort to explore relationships among key subgroups.

methodsWe 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.

resultsMean 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.

conclusionsNAVIGATE-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.

Indexed as

AgedAged, 80 and overAge FactorsAspirinComorbidityDouble-Blind MethodFactor Xa InhibitorsFemaleFibrinolytic AgentsHumansIntracranial EmbolismIschemic Attack, TransientMaleMiddle AgedPlatelet Aggregation InhibitorsRacial GroupsAspirinFactor Xa InhibitorsFibrinolytic AgentsPlatelet Aggregation InhibitorsRivaroxabanaspirincerebral embolismcryptogenic strokeEmbolic Stroke of Undetermined Source (ESUS)randomized trialrivaroxabanStrokestroke prevention

Identifiers

PMID29525076
PMCPMC6701183
OpenAlexW2794081025

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.