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Anticoagulant
Asundexian for Stroke Prevention (OCEANIC-STROKE Trial)
Phase 3
Recruiting
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 31 months
Awards & highlights
Summary
This trial is testing asundexian, a new medicine that prevents blood clots, in people who had a non-heart-related stroke or high-risk mini-stroke. The goal is to see if it works better at reducing future strokes without increasing bleeding risks. Asundexian is developed by Bayer AG and might prevent thrombosis without increasing bleeding.
Who is the study for?
This trial is for adults who've recently had a non-cardioembolic ischemic stroke or high-risk TIA/mini-stroke and are receiving standard antiplatelet therapy. It's not for those with strokes from rare causes, atrial fibrillation/flutter, heart-related blood clots, or mechanical valves needing anticoagulation.
What is being tested?
The study tests if Asundexian, a new anticoagulant tablet taken daily for 3 to 31 months alongside standard therapy, is more effective than a placebo at preventing further ischemic strokes without increasing bleeding risks.
What are the potential side effects?
Potential side effects include major bleeding events that could significantly impact health. Other possible adverse events will be monitored throughout the study via regular check-ups and questionnaires.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 31 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 31 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Time to first occurrence of ISTH major bleeding
Secondary study objectives
Time to first occurrence of composite of CV death, MI or stroke
Time to first occurrence of disabling stroke (mRS ≥3 at 90 days)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AsundexianExperimental Treatment1 Intervention
Participants will receive asundexian.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Asundexian (BAY2433334)
2022
Completed Phase 1
~30
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Transient Ischemic Attack (TIA) include antiplatelet and anticoagulant therapies. Antiplatelet drugs, such as aspirin and clopidogrel, work by preventing platelets from clumping together, thereby reducing the formation of blood clots.
Anticoagulants, like warfarin and newer agents such as asundexian, interfere with the blood clotting process by targeting specific factors in the coagulation cascade. These treatments are crucial for TIA patients as they help prevent the formation of clots that can lead to subsequent strokes, significantly reducing the risk of future ischemic events.
Clinical Effects of Dual Antiplatelet Therapy or Aspirin Monotherapy after Acute Minor Ischemic Stroke or Transient Ischemic Attack, a Meta-Analysis.Treatment and Outcome of Hemorrhagic Transformation After Intravenous Alteplase in Acute Ischemic Stroke: A Scientific Statement for Healthcare Professionals From the American Heart Association/American Stroke Association.Inhibition of factor IX(a) is protective in a rat model of thromboembolic stroke.
Clinical Effects of Dual Antiplatelet Therapy or Aspirin Monotherapy after Acute Minor Ischemic Stroke or Transient Ischemic Attack, a Meta-Analysis.Treatment and Outcome of Hemorrhagic Transformation After Intravenous Alteplase in Acute Ischemic Stroke: A Scientific Statement for Healthcare Professionals From the American Heart Association/American Stroke Association.Inhibition of factor IX(a) is protective in a rat model of thromboembolic stroke.
Find a Location
Who is running the clinical trial?
BayerLead Sponsor
2,268 Previous Clinical Trials
25,496,323 Total Patients Enrolled
2 Trials studying Transient Ischemic Attack
245 Patients Enrolled for Transient Ischemic Attack
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a heart condition that requires blood thinners.I am 18 years old or older.I recently had a stroke that wasn't caused by a heart issue.I have had a stroke or have artery problems in my brain or body.I had a stroke caused by a blood clot less than a week ago.My stroke was caused by a procedure or a rare condition.
Research Study Groups:
This trial has the following groups:- Group 1: Asundexian
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Transient Ischemic Attack Patient Testimony for trial: Trial Name: NCT05686070 — Phase 3
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