Milvexian
DrugMilvexian will be administered orally.
Other names: JNJ-70033093, BMS-986177
NCT Number: NCT05754957
The purpose of this study is to evaluate that milvexian is superior to placebo, in addition to standard-of-care, in reducing the risk of major adverse cardiovascular event (MACE) (the composite of cardiovascular [CV] death, myocardial infarction [MI], and ischemic stroke).
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Hospital Espanol De Bahia Blanca, Bahía Blanca, 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 3 years 6 months
Time to first occurrence of any component of MACE will be reported. MACE is a composite of cardiovascular (CV) death, myocardial infarction (MI), and ischemic stroke.
Time frame: Up to 3 years 6 months
Time to first occurrence of any component of MAVE will be reported. MAVE is a composite of CV death, MI, ischemic stroke, major adverse limb event (MALE), and symptomatic venous thromboembolism (VTE).
Time frame: Up to 3 years 6 months
Time to the first occurrence of composite of ACM, MI and ischemic stroke will be reported.
Time frame: Up to 3 years 6 months
Time to CV death will be reported.
Time frame: Up to 3 years 6 months
Time to ACM will reported. ACM will be categorized into CV death, non-CV death, and death due to unknown cause.
Janssen Research & Development, LLC
Industry
A Phase 3, Randomized, Double-blind, Placebo-controlled, Event-driven Study to Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, After a Recent Acute Coronary Syndrome
Acronym: LIBREXIA-ACS
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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