A Phase 3, Randomized, Double-Blind, Placebo-controlled, Event-driven Study to Demonstrate the Efficacy and Safety of an Oral Factor XIa Inhibitor, after a Recent Acute Coronary Syndrome (Milvexian ACS)

Description: 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).

Background: The purpose of this clinical study is to determine whether the addition of an oral Factor XIa Inhibitor to single antiplatelet therapy (SAPT) or dual antiplatelet therapy (DAPT) is more effective than standard therapy (SAPT or DAPT alone) in prevention of major adverse vascular events (MAVE), the events (MALE), and symptomatic venous thromboembolism (VTE).

Study Type: Interventional (Clinical Trial)

Background Therapy: Standard of care SAPT or DAPT (as a combination of aspirin and a P2Y12 inhibitor {clopidogrel or ticagrelor }) as determined by the treating physician.

Sample size: Global-16,000 and India-487

Updated as on: February 2024

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