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A Study to Test Asundexian to Prevent a Clot-related Stroke in Participants After an Acute Ischemic Stroke or High-risk TIA/Mini-stroke (Transient Ischemic Attack) (OCEANIC-STROKE)

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ClinicalTrials.gov Identifier: NCT05686070
Recruitment Status : Recruiting
First Posted : January 17, 2023
Last Update Posted : September 7, 2023
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief 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 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.


Condition or disease Intervention/treatment Phase
Prevention of Ischemic Stroke Acute Non-cardioembolic Ischemic Stroke High-risk Transient Ischemic Attack Drug: Asundexian (BAY2433334) Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 26, 2023
Estimated Primary Completion Date : October 10, 2025
Estimated Study Completion Date : October 10, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Time to first occurrence of ischemic stroke [ Time Frame: Up to 31 months ]
  2. Time to first occurrence of ISTH major bleeding [ Time Frame: Up to 31 months ]
    ISTH=International Society on Thrombosis and Hemostasis


Secondary Outcome Measures :
  1. Time to first occurrence of all strokes (ischemic and hemorrhagic) [ Time Frame: Up to 31 months ]
  2. Time to first occurrence of composite of CV death, MI or stroke [ Time Frame: Up to 31 months ]
    CV=Cardiovascular, MI=Myocardial infarction

  3. Time to first occurrence of composite of all-cause mortality, MI or stroke [ Time Frame: Up to 31 months ]
  4. Time to first occurrence of disabling stroke (mRS ≥3 at 90 days) [ Time Frame: Up to 31 months ]
    mRS=Modified Rankin Scale

  5. Time to first occurrence of all-cause mortality [ Time Frame: Up to 31 months ]
  6. Time to first occurrence of transient ischemic attack (TIA) [ Time Frame: Up to 31 months ]
  7. Time to first occurrence of composite of ISTH major or clinically relevant non-major bleeding [ Time Frame: Up to 31 months ]
  8. Time to first occurrence of ISTH clinically relevant non-major bleeding [ Time Frame: Up to 31 months ]
  9. Time to first occurrence of symptomatic intracranial hemorrhage [ Time Frame: Up to 31 months ]
  10. Time to first occurrence of hemorrhagic stroke [ Time Frame: Up to 31 months ]
  11. Time to first occurrence of fatal bleeding [ Time Frame: Up to 31 months ]
  12. Time to first occurrence of minor bleeding [ Time Frame: Up to 31 months ]
  13. Time to first occurrence of composite of ischemic stroke or ISTH major bleeding [ Time Frame: Up to 31 months ]
  14. Time to first occurrence of composite of CV death, all stroke, MI or ISTH major bleeding [ Time Frame: Up to 31 months ]
  15. Time to first occurrence of composite of all-cause mortality, disabling stroke, fatal bleeding, symptomatic intracranial hemorrhage [ Time Frame: Up to 31 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05686070


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

Locations
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Sponsors and Collaborators
Bayer
More Information
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Additional Information:

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT05686070    
Other Study ID Numbers: 20604
2023-503793-20-00 ( Other Identifier: CTIS (EU) )
2022-001067-27 ( EudraCT Number )
First Posted: January 17, 2023    Key Record Dates
Last Update Posted: September 7, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebral Infarction
Ischemic Attack, Transient
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Infarction
Necrosis