Summary

Eligibility
for people ages 40 years and up (full criteria)
Location
at UC Irvine UCLA
Dates
study started
completion 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, Stroke, Ischemic Stroke, Cerebral Infarction, Transient Ischemic Attack, Ischemia, Milvexian

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 California 92697 United States
  • Harbor Ucla Medical Center accepting new patients
    Torrance California 90502 United States
  • California Pacific Medical Center accepting new patients
    San Francisco California 94115 United States
  • Kaiser Permanente Northern California accepting new patients
    Oakland California 94612 United States
  • Alta Bates Medical Center Cancer Center accepting new patients
    Berkeley California 94705 United States
  • Glendale Adventist Medical Center accepting new patients
    Glendale California 91206 United States
  • Mills-Peninsula Health Services accepting new patients
    Burlingame California 94010 United States
  • Sutter Health - Eden Medical Center accepting new patients
    Castro Valley California 94546 United States
  • Long Beach Memorial accepting new patients
    Long Beach California 90806 United States
  • Stanford Stroke Center accepting new patients
    Palo Alto California 94304-1419 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