What side effects are associated with this type of intervention?

The most common treatments for Transient Ischemic Attack (TIA) include anticoagulants and antiplatelet therapies. Anticoagulants, like the one being studied in the trial Asundexian, are known to increase the risk of bleeding, including major bleeding events such as gastrointestinal bleeding and intracranial hemorrhage. Antiplatelet therapies also carry a risk of bleeding, though typically to a lesser extent. Specific side effects can vary depending on the exact medication used, but bleeding remains a primary concern for both types of treatments.

What prior FDA approvals exist?

The FDA has approved several anticoagulants for the prevention of strokes in patients with Transient Ischemic Attack (TIA). Notable among these are warfarin, which inhibits vitamin K-dependent clotting factors, and newer direct oral anticoagulants (DOACs) such as dabigatran, rivaroxaban, apixaban, and edoxaban, which directly inhibit thrombin or factor Xa. These medications work by interfering with the blood clotting process, similar to the investigational drug Asundexian, which aims to provide further treatment options without increasing the risk of bleeding.

What other types of research exist?

Promising novel alternatives to Asundexian for TIA patients include: <ol> <li>Edoxaban: An oral factor Xa inhibitor that has shown efficacy in preventing stroke and systemic embolism in patients with atrial fibrillation.</li> <li></li> </ol> Apixaban: Another oral factor Xa inhibitor that has been effective in thromboprophylaxis after orthopedic surgeries and could be considered for TIA patients. 3. Dabigatran: An oral direct thrombin inhibitor that has been compared favorably with warfarin for stroke prevention in atrial fibrillation patients. These alternatives offer potential options for TIA patients considering treatment in 2024.

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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

Pivotal Trial

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 31 months for reporting.

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)

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

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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.