Milvexian
DrugMilvexian will be administered orally.
Other names: JNJ-70033093, BMS-986177
NCT Number: NCT05702034
The purpose of this study is to evaluate whether milvexian compared to placebo reduce the risk of recurrent ischemic stroke.
This study is active but is not currently recruiting participants.
Notify Me40 year and older
All sexes
Interventional
Phase 3
Fundacion Favaloro, Buenos Aires, Argentina
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Milvexian will be administered orally.
Other names: JNJ-70033093, BMS-986177
Placebo will be administered orally
Time frame: Up to global targeted endpoint date (approximately 41 months)
Time to first occurrence of ischemic stroke will be reported.
Time frame: Up to global targeted endpoint date (approximately 41 months)
Time to first occurrence of any component of the composite of CVD, MI, or ischemic stroke will be reported.
Time frame: Up to Day 90
Time to first occurrence of ischemic stroke in the first 90 days will be reported.
Time frame: Up to global targeted endpoint date (approximately 41 months)
Time to first occurrence of any component of MAVE will be reported. MAVE is a composite of (CVD), myocardial infarction (MI), ischemic stroke, major adverse limb events (MALE), symptomatic pulmonary embolism (PE) or deep vein thrombosis (DVT).
Janssen Research & Development, LLC
Industry
A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, for Stroke Prevention After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack
Acronym: LIBREXIA-STROK
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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