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

NCT05686070
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Phase
Phase 3
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Recruitment status
Completed
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Participants
12,327
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Lead sponsor
Bayer
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Start date
2023-01-26
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Number of sites
741
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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 treatment group, the participants will either take asundexian or placebo 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.
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Acronym
OCEANIC-STROKE
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Short title
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
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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
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 3
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Study type
Interventional
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Completion date
2025-10-23
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First posted
2023-01-17
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Registry last updated
2025-11-12
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Primary completion date
2025-10-23
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Start date
2023-01-26
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Actual participants
12,327
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Participants
12,327
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Participant count basis
Actual
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Protocol amendments
5
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Number of sites
741
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Bayer
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05686070
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ClinicalTrials.gov ID
NCT05686070
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Time to first occurrence of ischemic stroke

    Timeframe: Up to 31 months

  2. Time to first occurrence of ISTH major bleeding

    Timeframe: Up to 31 months

    ISTH=International Society on Thrombosis and Hemostasis

  1. Time to first occurrence of all strokes (ischemic and hemorrhagic)

    Timeframe: Up to 31 months

  2. Time to first occurrence of composite of CV death, MI or stroke

    Timeframe: Up to 31 months

    CV=Cardiovascular, MI=Myocardial infarction

  3. Time to first occurrence of composite of all-cause mortality, MI or stroke

    Timeframe: Up to 31 months

  4. Time to first occurrence of disabling stroke (mRS ≥3 at 90 days)

    Timeframe: Up to 31 months

    mRS=Modified Rankin Scale

  5. Time to first occurrence of all-cause mortality

    Timeframe: Up to 31 months

  6. Time to first occurrence of transient ischemic attack (TIA)

    Timeframe: Up to 31 months

  7. Time to first occurrence of composite of ISTH major or clinically relevant non-major bleeding

    Timeframe: Up to 31 months

  8. Time to first occurrence of ISTH clinically relevant non-major bleeding

    Timeframe: Up to 31 months

  9. Time to first occurrence of symptomatic intracranial hemorrhage

    Timeframe: Up to 31 months

  10. Time to first occurrence of hemorrhagic stroke

    Timeframe: Up to 31 months

  11. Time to first occurrence of fatal bleeding

    Timeframe: Up to 31 months

  12. Time to first occurrence of minor bleeding

    Timeframe: Up to 31 months

  13. Time to first occurrence of composite of ischemic stroke or ISTH major bleeding

    Timeframe: Up to 31 months

  14. Time to first occurrence of composite of CV death, all stroke, MI or ISTH major bleeding

    Timeframe: Up to 31 months

  15. Time to first occurrence of composite of all-cause mortality, disabling stroke, fatal bleeding, symptomatic intracranial hemorrhage

    Timeframe: Up to 31 months

  16. Time to first occurrence of ischemic stroke in the first 90 days

    Timeframe: Up to 31 months

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

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

  • 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
Sources for eligibility
clinicaltrials.gov

  • Eastern Shore Research Institute, LLC | Fairhope, ALFairhope, United States
  • Barrow Neurologic Institute - Petznick Stroke CenterPhoenix, United States
  • HonorHealth Research InstituteScottsdale, United States
  • Banner - University Medical Center Tucson - NeurologyTucson, United States
  • University of Arkansas for Medical Sciences - NeurologyLittle Rock, United States
  • Kaiser Permanente Fontana Medical CenterFontana, United States
  • Long Beach Medical Center - NeurologyLong Beach, United States
  • Kaiser Permanente Los Angeles Medical Center - NeurologyLos Angeles, United States
  • Los Angeles - USC Healthcare Center 2 - NeurologyLos Angeles, United States
  • UCLA NeuroTranslational Research CenterLos Angeles, United States
  • Hoag Memorial Hospital - Center for Research & EducationNewport Beach, United States
  • UCI Medical Center - NeurologyOrange, United States
  • San Francisco VA Health Care SystemSan Francisco, United States
  • Cottage Health | Santa Barbara Cottage Hospital - Research DepartmentSanta Barbara, United States
  • The Lundquist Institute - NeurologyTorrance, United States
  • St. Vincent's Medical Center - Neurology ClinicBridgeport, United States
  • Nuvance HealthDanbury, United States
  • Yale University | School of Medicine - Department of NeurologyNew Haven, United States
  • ChristianaCare Health Services | Christiana Hospital - Emergency Medicine ResearchNewark, United States
  • HCA Florida JFK Hospital - NeurologyAtlantis, United States
  • Delray Medical Center - NeurologyBoynton Beach, United States
  • Nova Clinical Research - Blake Medical CenterBradenton, United States
  • BayCare Health System | Morton Plant Hospital - Neuroscience Research departmentClearwater, United States
  • UF Health Neuromedicine HospitalGainesville, United States
  • Baptist Health Research InstituteJacksonville, United States

And 716 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2023
  • 2023-503793-20-00
  • 2022-001067-27
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)