> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-test-asundexian-for-preventing-a-stroke-caused-by-24602979-43e8-4a6c-b4c8-a393f5823d5e > Record changed: 2026-11-04 # 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686070) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686070) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686070) Participants 12,327 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686070) Lead sponsor Bayer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686070) Start date 2023-01-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686070) Number of sites 741 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686070) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686070) **Acronym** OCEANIC-STROKE Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686070) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686070) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686070) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686070) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686070) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686070) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686070) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686070) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686070) ## Dates **Completion date** 2025-10-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686070) **First posted** 2023-01-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686070) **Registry last updated** 2025-11-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686070) **Primary completion date** 2025-10-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686070) **Start date** 2023-01-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686070) ## Size and sites **Actual participants** 12,327 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686070) **Participants** 12,327 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686070) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686070) **Protocol amendments** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686070) **Number of sites** 741 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686070) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686070) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686070) **Lead sponsor** Bayer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686070) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686070) ## Identifiers **Registry ID** NCT05686070 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686070) **ClinicalTrials.gov ID** NCT05686070 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686070) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686070) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686070) ## Outcomes ### Primary outcomes 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 ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686070) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686070) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686070) ## References - PubMed 41985132 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/41985132/) Related publication - PubMed 41614533 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/41614533/) Related publication ### Other registry identifiers (3) - 2023 - 2023-503793-20-00 - 2022-001067-27 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686070) ## Related records ### Drugs (1) - [Asundexian](https://trialight.com/data/asset/asundexian-76d6790a-4f6b-5f91-a5de-7c6e8a6cc42d.md) ### Lead sponsors (1) - [Bayer](https://trialight.com/data/company/bayer-42b54973-255a-4794-b8f8-448b5798cc39.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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