What side effects are associated with this type of intervention?

Common treatments for atrial fibrillation, particularly oral anticoagulants like apixaban, are primarily aimed at reducing the risk of stroke and systemic embolism by preventing blood clot formation. The most significant side effect of these anticoagulants is an increased risk of bleeding, which can range from minor to major and life-threatening bleeding events. Other potential side effects may include gastrointestinal issues, liver enzyme abnormalities, and, in rare cases, allergic reactions. Newer anticoagulants like asundexian are being studied for their potential to offer similar benefits with a reduced risk of bleeding.

What prior FDA approvals exist?

The FDA has approved several anticoagulants for the treatment of Atrial Fibrillation to reduce the risk of stroke and systemic embolism. Notable among these are warfarin, a vitamin K antagonist, and newer non-vitamin K antagonist oral anticoagulants (NOACs) such as apixaban, rivaroxaban, dabigatran, and edoxaban. These NOACs have been favored for their predictable pharmacokinetics and lower risk of certain types of bleeding compared to warfarin. Apixaban, in particular, is being compared to the investigational drug Asundexian in current studies to evaluate its efficacy and safety in reducing blood clot formation with potentially lower bleeding risks.

What other types of research exist?

Promising novel alternatives to Asundexian for atrial fibrillation patients include other non-vitamin K antagonist oral anticoagulants (NOACs) such as dabigatran, rivaroxaban, and apixaban. These medications have been shown to be effective in preventing stroke and systemic embolism with varying safety profiles. Additionally, new oral direct thrombin inhibitors and direct Factor Xa inhibitors are being developed and may offer further options with potentially lower bleeding risks.

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Anticoagulant

Asundexian for Atrial Fibrillation and Stroke Prevention (OCEANIC-AF Trial)

Phase 3

Waitlist Available

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 34 months

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new medication called asundexian to prevent strokes in people with irregular heartbeats. The study will compare asundexian to an existing drug, apixaban, to see which one works better and is safer. Participants will take the medication for an extended period and have regular check-ups.

Who is the study for?

This trial is for adults with atrial fibrillation, an irregular heartbeat that increases stroke risk. Participants need a certain score indicating high stroke risk (CHA2DS2-VASc score) and must require long-term oral anticoagulant treatment. People with mechanical heart valves, severe mitral valve narrowing, temporary atrial fibrillation, or needing blood thinners for other conditions cannot join.

What is being tested?

The study compares the effectiveness and safety of two oral anticoagulants: Asundexian and Apixaban. It aims to see which drug better prevents strokes or systemic embolism without causing major bleeding. Participants are randomly assigned to take either Asundexian once daily or Apixaban twice daily for about 9-33 months.

What are the potential side effects?

As both medications are blood thinners designed to prevent clotting, the main side effect being monitored is increased bleeding risk. This can range from minor bruising to serious or life-threatening bleeds.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 34 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 34 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 34 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 CV death

Time to first occurrence of composite of disabling stroke (mRS ≥ 3), critical bleeding, or all-cause mortality

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

Active Control

Group I: AsundexianExperimental Treatment2 Interventions

Participants will receive asundexian and apixaban matching placebo.

Group II: ApixabanActive Control2 Interventions

Participants will receive apixaban and asundexian matching placebo.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Asundexian (BAY2433334)

2022

Completed Phase 1

~30

Apixaban matching placebo

2020

Completed Phase 2

~760

Do I qualify?Apply below to find out

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 Atrial Fibrillation (AF) include anticoagulants like apixaban and the investigational drug asundexian. These medications work by inhibiting specific factors in the blood coagulation pathway, thereby reducing the formation of blood clots. Apixaban, for example, inhibits Factor Xa, which is essential for the conversion of prothrombin to thrombin, a key step in clot formation. Asundexian aims to provide similar anticoagulant effects but with a potentially lower risk of bleeding. This is particularly important for AF patients, as they are at high risk for stroke due to clot formation in the heart. Effective anticoagulation can significantly reduce this risk, improving patient outcomes and quality of life.

Do computerized clinical decision support systems improve the prescribing of oral anticoagulants? A systematic review.Antiplatelet versus anticoagulant therapies in advanced age: an unfinished task.