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.
Aspirin
/ adverse effects
Clopidogrel
/ therapeutic use
Double-Blind Method
Drug Therapy, Combination
Factor XIa
Fibrinolytic Agents
/ adverse effects
Hemorrhage
Humans
Ischemic Attack, Transient
/ diagnostic imaging
Ischemic Stroke
Platelet Aggregation Inhibitors
/ therapeutic use
Secondary Prevention
Stroke
/ diagnostic imaging
Thromboembolism
/ drug therapy
Treatment Outcome
Factor XI
MRI
Milvexian
Randomized trial
Stroke
Stroke prevention
Journal
Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association
ISSN: 1532-8511
Titre abrégé: J Stroke Cerebrovasc Dis
Pays: United States
ID NLM: 9111633
Informations de publication
Date de publication:
Oct 2022
Oct 2022
Historique:
received:
13
06
2022
revised:
12
08
2022
accepted:
17
08
2022
pubmed:
30
8
2022
medline:
28
9
2022
entrez:
29
8
2022
Statut:
ppublish
Résumé
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. We 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 The AXIOMATIC-SSP trial will evaluate the dose-response of milvexian for ischemic stroke occurrence in participants with ischemic stroke or TIA.
Sections du résumé
BACKGROUND
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
METHODS
We 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
CONCLUSION
CONCLUSIONS
The AXIOMATIC-SSP trial will evaluate the dose-response of milvexian for ischemic stroke occurrence in participants with ischemic stroke or TIA.
Identifiants
pubmed: 36037679
pii: S1052-3057(22)00436-0
doi: 10.1016/j.jstrokecerebrovasdis.2022.106742
pmc: PMC9619293
mid: NIHMS1840374
pii:
doi:
Substances chimiques
Fibrinolytic Agents
0
Platelet Aggregation Inhibitors
0
Clopidogrel
A74586SNO7
Factor XIa
EC 3.4.21.27
Aspirin
R16CO5Y76E
Types de publication
Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
106742Subventions
Organisme : NHLBI NIH HHS
ID : R35 HL140025
Pays : United States
Informations de copyright
Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.
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