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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

2022· article· en· W4293678347 on OpenAlexaff
Mukul Sharma, Carlos A. Molina, Ḱazunori Toyoda, Dániel Bereczki, Scott E. Kasner, Helmi L. Lutsep, Georgios Tsivgoulis, George Ntaios, Anna Członkowska, Ashfaq Shuaib, Pierre Amarenco, Matthias Endres, Hans‐Christoph Diener, David Gailani, Anja Kahl, Mark Donovan, Vidya Perera, Danshi Li, Graeme J. Hankey

Bibliographic record

VenueJournal of Stroke and Cerebrovascular Diseases · 2022
Typearticle
Languageen
FieldMedicine
TopicCoagulation, Bradykinin, Polyphosphates, and Angioedema
Canadian institutionsAlberta Hospital EdmontonUniversity of Alberta HospitalPopulation Health Research InstituteMcMaster University
FundersJanssen Research and DevelopmentDeutsches Zentrum für Neurodegenerative ErkrankungenDaiichi Sankyo EuropeSanofiDeutsches Zentrum für Herz-KreislaufforschungKowa CompanyIonis PharmaceuticalsAlexion PharmaceuticalsAmgenNational Heart, Lung, and Blood InstitutePfizerBristol-Myers SquibbAstraZenecaNovo NordiskAmerican Heart Association
KeywordsMedicineClopidogrelStroke (engine)AspirinClinical endpointInternal medicineRandomized controlled trialPlaceboPhysical therapyPathology

Abstract

fetched live from OpenAlex

BACKGROUND: Individuals 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. METHODS: score ≥6) were randomized to 1 of 5 doses of milvexian or placebo for 90 days. Participants also received clopidogrel 75 mg daily for the first 21 days and aspirin 100 mg for 90 days. The efficacy endpoint was the composite of ischemic stroke or incident infarct on magnetic resonance imaging. Major bleeding, defined as type 3 or 5 bleeding according to the Bleeding Academic Research Consortium, was the safety endpoint. Participant follow-up will end in 2022. CONCLUSION: The AXIOMATIC-SSP trial will evaluate the dose-response of milvexian for ischemic stroke occurrence in participants with ischemic stroke or TIA.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.

metaresearch head score (Codex)0.043
metaresearch head score (Gemma)0.034
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Not applicable · Consensus signal: none
GenreCandidate signal: Protocol · Consensus signal: Protocol
Teacher disagreement score0.043
Threshold uncertainty score0.226

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0430.034
Meta-epidemiology (narrow)0.0040.002
Meta-epidemiology (broad)0.0050.003
Bibliometrics0.0010.001
Science and technology studies0.0020.003
Scholarly communication0.0030.002
Open science0.0030.001
Research integrity0.0050.006
Insufficient payload (model declined to judge)0.0120.004

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.024
GPT teacher head0.283
Teacher spread0.259 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designNot applicable
Domainnot available
GenreProtocol

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations39
Published2022
Admission routes1
Has abstractyes

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