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NCT05686070 · ClinicalTrials.gov registry record · Phase 3
A Study to Test Asundexian for Preventing a Stroke Caused by a Clot in Participants After an Acute Ischemic Stroke or After a High-risk Transient Ischemic Attack, a So-called Mini Stroke
A Phase 3 study of Acute Non-cardioembolic Ischemic Stroke and Prevention of Ischemic Stroke, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 12,327
- Enrollment target
- 20
- Study locations
NCT05686070 is a Phase 3 study of Acute Non-cardioembolic Ischemic Stroke and Prevention of Ischemic Stroke that has completed, run by Bayer. The registered enrollment target is 12,327 participants. The trial reports 20 study locations across 7 states.
The verdict
NCT05686070, a Phase 3 study of Acute Non-cardioembolic Ischemic Stroke and Prevention of Ischemic Stroke, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 12,327 participants
- Enrollment target
- 20
- Study locations
Study 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: * 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 treat
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Asundexian (BAY2433334)
Study Locations (20)
California
- Kaiser Permanente Fontana Medical Center - Fontana
- Long Beach Medical Center - Neurology - Long Beach
- Kaiser Permanente Los Angeles Medical Center - Neurology - Los Angeles
- Los Angeles - USC Healthcare Center 2 - Neurology - Los Angeles
- UCLA NeuroTranslational Research Center - Los Angeles
- Hoag Memorial Hospital - Center for Research & Education - Newport Beach
- UCI Medical Center - Neurology - Orange
- San Francisco VA Health Care System - San Francisco
- Cottage Health | Santa Barbara Cottage Hospital - Research Department - Santa Barbara
- The Lundquist Institute - Neurology - Torrance
Arizona
- Barrow Neurologic Institute - Petznick Stroke Center - Phoenix
- HonorHealth Research Institute - Scottsdale
- Banner - University Medical Center Tucson - Neurology - Tucson
Connecticut
- St. Vincent's Medical Center - Neurology Clinic - Bridgeport
- Nuvance Health - Danbury
- Yale University | School of Medicine - Department of Neurology - New Haven
Alabama
- Eastern Shore Research Institute, LLC | Fairhope, AL - Fairhope
Arkansas
- University of Arkansas for Medical Sciences - Neurology - Little Rock
Delaware
- ChristianaCare Health Services | Christiana Hospital - Emergency Medicine Research - Newark
Florida
- HCA Florida JFK Hospital - Neurology - Atlantis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12,327 participants |
| Start Date | 2023-01-26 |
| Est. Completion | 2025-10-23 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05686070
The ClinicalTrials.gov registry entry for NCT05686070 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 12,327 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Acute Non-cardioembolic Ischemic Stroke appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05686070 reports 20 study locations spanning 7 distinct geographic areas - top geographies include California, Arizona, Connecticut.
Frequently Asked Questions
What is clinical trial NCT05686070 about?
NCT05686070 is a clinical study titled "A Study to Test Asundexian for Preventing a Stroke Caused by a Clot in Participants After an Acute Ischemic Stroke or After a High-risk Transient Ischemic Attack, a So-called Mini Stroke". 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-strok...
What is the current status of trial NCT05686070?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 12,327 participants. The study started on 2023-01-26. Estimated completion is 2025-10-23.
What conditions does trial NCT05686070 study?
This clinical trial studies the following conditions: Acute Non-cardioembolic Ischemic Stroke, Prevention of Ischemic Stroke, High-risk Transient Ischemic Attack.
What interventions are being tested in trial NCT05686070?
The interventions under investigation include: Placebo (DRUG), Asundexian (BAY2433334) (DRUG).
Who is sponsoring clinical trial NCT05686070?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05686070 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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