Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion

Description

Summary

Researchers are looking for a better way to prevent an ischemic stroke which occurs when a blood clot travelled to the brain in people who within the last 72 hours had:

  • a stroke due to a blood clot that formed outside the heart (acute non-cardioembolic ischemic stroke), or
  • temporary stroke-like symptoms with a high risk of turning into a stroke (high-risk transient ischemic attack), and who are planned to receive standard of care therapy. Ischemic strokes or transient ischemic attacks result from a blocked or reduced blood flow to a part of the brain. They are caused by blood clots that travel to the brain and block the vessels that supply it. If these blood clots form elsewhere than in the heart, the stroke is called non-cardioembolic. People who already had a non-cardioembolic stroke are more likely to have another stroke. This is why they are treated preventively with an antiplatelet therapy, the current standard of care. Antiplatelet medicines prevent platelets, components of blood clotting, from clumping together.

Anticoagulants are another type of medicine that prevents blood clots from forming by interfering with a process known as coagulation (or blood clotting).

The study treatment asundexian is a new type of anticoagulant currently under development to provide further treatment options. The way it works, it aims to further improve the standard of care with regard to the risk of bleeding.

The main purpose of this study is to learn whether asundexian works better than placebo at reducing ischemic strokes in participants who recently had a non-cardioembolic ischemic stroke or temporary stroke-like symptoms when given in addition to standard antiplatelet therapy. A placebo is a treatment that looks like a medicine but does not have any medicine in it.

Another aim is to compare the occurrence of major bleeding events during the study between the asundexian and the placebo group. Major bleedings have a serious or even life-threatening impact on a person's health.

Dependent on the treatment group, the participants will either take asundexian or placebo as tablets once a day for at least 3 months up to 31 months.

Approximately every 3 months during the treatment period, either a phone call or a visit to the study site is scheduled on an alternating basis. In addition, one visit before and up to two visits after the treatment period are planned.

During the study, the study team will:

  • Check vital signs such as blood pressure and heart rate
  • Examine the participants' heart health using an electrocardiogram (ECG)
  • Take blood samples
  • Ask the participants questions about how they are feeling and what adverse events they are having.

An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. In addition, the participants will be asked to complete a questionnaire on quality of life at certain time points during the study.

Official Title

A Multicenter, International, Randomized, Placebo Controlled, Double-blind, Parallel Group and Event Driven Phase 3 Study of the Oral FXIa Inhibitor Asundexian (BAY 2433334) for the Prevention of Ischemic Stroke in Male and Female Participants Aged 18 Years and Older After an Acute Non-cardioembolic Ischemic Stroke or High-risk TIA

Keywords

Prevention of Ischemic Stroke, Acute Non-cardioembolic Ischemic Stroke, High-risk Transient Ischemic Attack, Stroke, Ischemic Stroke, Cerebral Infarction, Transient Ischemic Attack, Ischemia, Asundexian (BAY2433334), Asundexian

Eligibility

You can join if…

Open to people ages 18 years and up

  • Participants must be ≥ 18 years of age
  • Acute non-cardioembolic stroke or high-risk TIA
  • Systemic or cerebrovascular atherosclerosis or acute non-lacunar infarct

You CAN'T join if...

  • Ischemic stroke ≤ 7 days before the index stroke event
  • Index stroke following procedures or strokes due to other rare causes
  • History of atrial fibrillation/flutter, left ventricular thrombus, mechanic valve or other cardioembolic source of stroke requiring anticoagulation

Locations

  • UC Irvine Medical Center not yet accepting patients
    Orange California 92868 United States
  • Hoag Memorial Hospital - Center for Research & Education not yet accepting patients
    Newport Beach California 92663 United States
  • MemorialCare Health System not yet accepting patients
    Long Beach California 90801 United States
  • University of Southern California Keck School of Medicine not yet accepting patients
    Los Angeles California 90089 United States
  • Ronald Reagan UCLA Medical Center not yet accepting patients
    Los Angeles California 90095 United States
  • Harbor - UCLA Medical Center not yet accepting patients
    Torrance California 90502 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Bayer
Links
Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.
ID
NCT05686070
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 9300 study participants
Last Updated