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Purpose

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: - an acute stroke due to a blood clot that formed outside the heart (acute non-cardioembolic ischemic stroke), or - TIA/mini-stroke with a high risk of turning into a stroke (high-risk transient ischemic attack), and who are planned to receive standard of care therapy. Acute ischemic strokes or TIA/mini-stroke 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. Asundexian aims to further improve the standard of care without increasing 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 TIA/mini-stroke 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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Ischemic stroke ≤ 7 days before the index 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Asundexian 		Participants will receive asundexian.
  • Drug: Asundexian (BAY2433334)
    Once daily, oral
Placebo Comparator
Placebo 		Participants will receive placebo.
  • Drug: Placebo
    Placebo to asundexian, once daily, oral

Recruiting Locations

Eastern Shore Research Institute, LLC | Fairhope, AL
Fairhope, Alabama 36532

St. Joseph's Hosp | Barrow Neuro Institute
Phoenix, Arizona 85013

Banner - University Medical Center Tucson
Tucson, Arizona 85719

MemorialCare Health System
Long Beach, California 90801

Kaiser Permanente Los Angeles Medical Center
Los Angeles, California 90027

University of Southern California Keck School of Medicine
Los Angeles, California 90033

Ronald Reagan UCLA Medical Center
Los Angeles, California 90095

UC Irvine Medical Center
Orange, California 92868

Yale University | School of Medicine - Department of Neurology
New Haven, Connecticut 06510

Cardiology Associates of Fairfield County, PC - Trumbull
Trumbull, Connecticut 06611

Christiana Care Health System
Newark, Delaware 19713

HCA Florida JFK Hospital
Atlantis, Florida 33462

Delray Medical Center
Boynton Beach, Florida 33472

Nova Clinical Research | Blake Medical Center Center
Bradenton, Florida 34243

BayCare Health System | Morton Plant Hospital, Neuroscience Research department
Clearwater, Florida 33756

University of Florida Health Sciences Center
Gainesville, Florida 32608

Intercoastal Medical Group | Clinical Research
Sarasota, Florida 34239

University of South Florida
Tampa, Florida 33606

University of Illinois at Chicago | Department of Neurology
Chicago, Illinois 60612

The University of Chicago
Chicago, Illinois 60637

Mercyhealth Javon Bea Hospital - Riverside | Neurology Research Department
Rockford, Illinois 61114

HSHS Medical Group
Springfield, Illinois 62769

Ochsner Health System | Ochsner Clinic Foundation - Neuroscience Research Department
New Orleans, Louisiana 70121-2429

Tufts Medical Center - Boston
Boston, Massachusetts 02111

Henry Ford Hospital
Detroit, Michigan 48202

Michigan State University
East Lansing, Michigan 48824

Trinity Health | Oakland Hospital - Clinical Research Department
Pontiac, Michigan 48341

Minneapolis Clinic of Neurology | Golden Valley, MN
Golden Valley, Minnesota 55422

Mayo Clinic - Rochester
Rochester, Minnesota 55905

St. Luke's Hospital of Kansas City
Kansas City, Missouri 64111

Kansas City VA Medical Center
Kansas City, Missouri 64128

Barnes-Jewish Hospital
Saint Louis, Missouri 63110

Mercy Hospital
Saint Louis, Missouri 63141

Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 03756

Albany Medical College | Department of Neurology
Albany, New York 12208

Northwell Health Neuroscience Institute
Great Neck, New York 11021-5209

Westchester Medical Center
Hawthorne, New York 10532

NYU Langone Medical Center
New York, New York 10016-6402

Icahn School of Medicine at Mount Sinai
New York, New York 10029-6500

Vassar Brothers Medical Center
Poughkeepsie, New York 12601

Duke Univ. Medical Center
Durham, North Carolina 27708

Guilford Neurologic Research, PA
Greensboro, North Carolina 27405

ECU Health Medical Center
Greenville, North Carolina 27834

Wake Forest University School of Medicine
Winston-Salem, North Carolina 27101-4135

Novant Health Forsyth Medical Center
Winston-Salem, North Carolina 27103

Cleveland Clinic Foundation
Cleveland, Ohio 44195

Ohio State University Wexner Medical Center
Columbus, Ohio 43210

OhioHealth Research Institute
Columbus, Ohio 43302-6225

Wright State University | Boonshoft School of Medicine - WSU and Premier Health Clinical Trials Research Alliance
Fairborn, Ohio 45324

Kettering Health Network | Research Institute
Kettering, Ohio 45429

ProMedica | ProMedica Toledo Hospital - Neuro/Stroke Research Department
Toledo, Ohio 43606

Mercy Health St. Elizabeth Youngstown Hospital
Youngstown, Ohio 44501

University of Oklahoma Med Center
Oklahoma City, Oklahoma 73104

Oregon Health and Science University
Portland, Oregon 97239

Lehigh Neurology
Allentown, Pennsylvania 18103

University of Pittsburgh Medical Center, Hamot | Clinical Trials and Research
Erie, Pennsylvania 16550

University of Pittsburgh Medical Center
Harrisburg, Pennsylvania 17101

Lancaster General Hospital
Lancaster, Pennsylvania 17602

The Hospitals of the University of Pennsylvania
Philadelphia, Pennsylvania 19104

Thomas Jefferson University
Philadelphia, Pennsylvania 19107

Lewis Katz School of Medicine at Temple University - Neurolo
Philadelphia, Pennsylvania 19140

Rhode Island Hospital
Providence, Rhode Island 02903

Prisma Health | PH Greenville Memorial Hospital - Cerebrovascular & Stroke Center of the Neurology Department - Stroke Program
Greenville, South Carolina 29605

Erlanger Health, Inc.
Chattanooga, Tennessee 37403

University of Tennessee Medical Center
Knoxville, Tennessee 37920

Baylor University Medical Center at Dallas
Dallas, Texas 75246

University of Texas Southwestern Medical Center
Dallas, Texas 75390-7208

Texas Health Harris Methodist Hospital
Fort Worth, Texas 76104

Houston Methodist Hospital
Houston, Texas 77030

University of Texas Health Science Center at Houston
Houston, Texas 77030

University of Texas Health San Antonio
San Antonio, Texas 78229

Baylor Scott & White
Temple, Texas 76508

Intermountain Healthcare | Cardiovascular Research Department
Murray, Utah 84107

Neurological Associates - Henrico
Henrico, Virginia 23229

University Physicians and Surgeons
Huntington, West Virginia 25701

Froedtert Health/Medical College of Wisconsin
Milwaukee, Wisconsin 53226

More Details

NCT ID
NCT05686070
Status
Recruiting
Sponsor
Bayer

Study Contact

Bayer Clinical Trials Contact
(+)1-888-84 22937
clinical-trials-contact@bayer.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.