Summary

Eligibility
for people ages 40 years and up (full criteria)
Location
at UC Davis UC Irvine UCLA
Dates
study started
study ends around

Description

Summary

The purpose of this study is to evaluate whether milvexian compared to placebo reduce the risk of recurrent ischemic stroke.

Official Title

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

Keywords

Ischemic Stroke; Ischemic Attack, Transient, Ischemic Stroke, milvexian, Counterfeit Drugs

Eligibility

You can join if…

Open to people ages 40 years and up

  • Ischemic Stroke: a neurological deficit attributable to an acute brain infarction and national institute of health stroke score scale (NIHSS) score less than or equal to (<=) 7 and at least 1 of the following: persistent signs or symptoms of the ischemic event at the time of randomization, or acute, ischemic brain lesion determined by standard-of-care neuroimaging, or participant underwent thrombolysis or thrombectomy, or transient ischemic attack (TIA): acute onset neurological deficit attributable to focal ischemia of the brain by history or examination, with complete symptom resolution of the deficit and no brain infarction on neuroimaging (example, computed tomography (CT) scan or magnetic resonance imaging (MRI), performed as part of standard medical practice), and ABCD2 Score greater than or equal to (>=) 6
  • Participants will be randomized as soon as possible after determining eligibility and within 48 hours of onset of event.
  • Current or planned antiplatelet treatment per international and/or local guidelines. If acetyl salicylic acid (ASA) is used, it will be limited to low dose (75 to 100 milligrams (mg)/day). Loading dose of antiplatelet agents (including ASA) are allowed per standard-of-care
  • A female participant must agree not to be pregnant, breastfeeding, or planning to become pregnant until 4 days (5 half lives) after the last dose of study intervention
  • Willing and able to adhere to the lifestyle restrictions specified in this protocol

You CAN'T join if...

  • Prior history of intracranial hemorrhage except subarachnoid hemorrhage greater than (>) 1 year prior with adequate treatment
  • The index stroke or TIA is considered to have a cardio-embolic etiology based on local standard-of-care investigations and for which guidelines recommend anticoagulation
  • The index stroke or TIA considered to have another known cause, not related to athero-thrombotic sources (treatment of acute stroke trial [TOAST] Other Determined Etiology), based on local standard-of-care investigations
  • Increased risk of bleeding, including clinically significant bleeding within the previous 3 months or known bleeding diathesis or known activated partial thromboplastin time (aPTT) prolongation or spinal cord hemorrhage or retinal hemorrhage
  • Current active liver disease, eg, acute hepatitis, known cirrhosis, including participants receiving antiviral treatment for hepatitis
  • Known allergies, hypersensitivity, or intolerance to milvexian or its excipients

Locations

  • UC Irvine Healthcare Center accepting new patients
    Irvine 5359777 California 5332921 92697 United States
  • University of California Davis Health System accepting new patients
    Sacramento 5389489 California 5332921 95817 United States
  • Harbor Ucla Medical Center completed
    Torrance 5403022 California 5332921 90502 United States
  • Pacific Neuroscience Institute accepting new patients
    Santa Monica 5393212 California 5332921 90404 United States
  • California Pacific Medical Center accepting new patients
    San Francisco 5391959 California 5332921 94115 United States
  • Providence Saint Joseph Medical Center - Cancer Center accepting new patients
    Burbank 5331835 California 5332921 91505 United States
  • Mission Hospital Regional Medical Center accepting new patients
    Mission Viejo 5373763 California 5332921 92691 United States
  • Alta Bates Medical Center Cancer Center accepting new patients
    Berkeley 5327684 California 5332921 94705 United States
  • Glendale Adventist Medical Center accepting new patients
    Glendale 5352423 California 5332921 91206 United States
  • Sharp Grossmont Hospital accepting new patients
    La Mesa 5363990 California 5332921 91942 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
ID
NCT05702034
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 15000 study participants
Last Updated