Evidence map›Paper›PMID 36037679›Full record

ArticleJournal of stroke and cerebrovascular diseases : the official journal of National Stroke Association2022

Rationale and design of the AXIOMATIC-SSP phase II trial: Antithrombotic treatment with factor XIa inhibition to Optimize Management of Acute Thromboembolic events for Secondary Stroke Prevention.

Mukul Sharma, Carlos A Molina, Kazunori Toyoda, Daniel Bereczki, Scott E Kasner, Helmi L Lutsep, Georgios Tsivgoulis, George Ntaios, Anna Czlonkowska, Ashfaq Shuaib and 9 more

Open access · hybridAbstract readClinical Trial Protocol
In one paragraph

Article in Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
6.0field-weighted citation impact, top 3% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 39 citations in OpenAlex.

  1. Guideline
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  7. Factor XIa inhibition as a therapeutic strategy for atherothrombosis.Journal of thrombosis and thrombolysis · 2024
    Review
  8. Factor XI: structure, function and therapeutic inhibition.Journal of thrombosis and thrombolysis · 2024
    Review
  9. Review
  10. Review
  11. Review
  12. Article
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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

19 authors at 16 institutions in 10 countries.

Mukul SharmaPopulation Health Research Institute, McMaster University, Hamilton, Ontario, Canada. Electronic address: mike.sharma@phri.ca.
Carlos A MolinaHospital Universitari Vall d´Hebron, Barcelona, Spain.
Kazunori ToyodaNational Cerebral and Cardiovascular Center, Osaka, Japan.
Daniel BereczkiSemmelweis University, Budapest, Hungary.
Scott E KasnerHospital of the University of Pennsylvania, Philadelphia, PA, USA.
Helmi L LutsepOregon Health and Science University, Portland, OR, USA.
Georgios TsivgoulisNational and Kapodistrian University of Athens, Attikon University Hospital, Athens, Greece.
George NtaiosUniversity of Thessaly, Larissa,Greece.
Anna CzlonkowskaInstitute of Psychiatry and Neurology, Warsaw, Poland.
Ashfaq ShuaibUniversity of Alberta Hospital, Edmonton, Alberta, Canada.
Pierre AmarencoUniversity of Paris, Bichat Hospital, Paris, France.
Matthias EndresDepartment Neurology and Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Berlin, Germany.
Hans Christoph DienerUniversity Duisburg-Essen, Essen, Germany.
David GailaniVanderbilt University Medical Center, Nashville, TN, USA.
Anja KahlBristol Myers Squibb, Princeton, NJ, USA.
Mark DonovanBristol Myers Squibb, Princeton, NJ, USA.
Vidya PereraBristol Myers Squibb, Princeton, NJ, USA.
Danshi LiBristol Myers Squibb, Princeton, NJ, USA.
Graeme J HankeyThe University of Western Australia, Perth, Australia; Perron Institute for Neurological and Translational Science, Perth, Australia.
Bristol-Myers Squibb (United States) · USCharité - Universitätsmedizin Berlin · DEHospital of the University of Pennsylvania · USInstitute of Psychiatry and Neurology · PLMcMaster University · CANational and Kapodistrian University of Athens · GRNational Cerebral and Cardiovascular Center · JPOregon Health & Science University · USPerron Institute for Neurological and Translational Science · AUSemmelweis University · HUUniversité Paris Cité · FRUniversity of Alberta Hospital · CAUniversity of Duisburg-Essen · DEUniversity of Thessaly · GRVall d'Hebron Hospital Universitari · ESVanderbilt University Medical Center · US

Funding

Biochemistry and Pathophysiology of Factor XI and Contact ActivationR35HL140025 · NHLBI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI GAILANI, DAVID · 2018 to 2024
$5.5M
NHLBI NIH HHS R35 HL140025
6 · The paper itself

Abstract

backgroundIndividuals with ischemic stroke or transient ischemic attack (TIA) have a high early risk of ischemic stroke despite dual antiplatelet therapy. The risk of ischemic stroke, and associated disability, represents a significant unmet clinical need. Genetic variants resulting in reduced factor XI levels are associated with reduced risk for ischemic stroke but are not associated with increased intracranial bleeding. Milvexian is an oral small-molecule inhibitor of FXIa that binds activated factor XI with high affinity and selectivity and may reduce the risk of stroke when added to antiplatelet drugs without significant bleeding. We aimed to evaluate the dose-response relationship of milvexian in participants treated with dual antiplatelets.

methodsWe began a phase II, double-blinded, randomized, placebo-controlled trial at 367 sites in 2019. Participants (N = 2366) with ischemic stroke (National Institutes of Health Stroke Scale score ≤7) or high-risk TIA (ABCD

conclusionThe AXIOMATIC-SSP trial will evaluate the dose-response of milvexian for ischemic stroke occurrence in participants with ischemic stroke or TIA.

Indexed as

Ischemic Attack, TransientIschemic StrokeStrokeThromboembolismAspirinClinical Trials, Phase II as TopicClopidogrelDouble-Blind MethodDrug Therapy, CombinationFactor XIaFibrinolytic AgentsHemorrhageHumansPlatelet Aggregation InhibitorsRandomized Controlled Trials as TopicSecondary PreventionAspirinClopidogrelFactor XIaFibrinolytic AgentsPlatelet Aggregation InhibitorsFactor XIMilvexianMRIRandomized trialStrokeStroke prevention

Identifiers

PMID36037679
PMCPMC9619293
OpenAlexW4293678347

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.