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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 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

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.

Find a Location

Who is running the clinical trial?

BayerLead Sponsor
2,270 Previous Clinical Trials
25,493,902 Total Patients Enrolled
95 Trials studying Atrial Fibrillation
2,256,170 Patients Enrolled for Atrial Fibrillation

Media Library

Apixaban (Anticoagulant) Clinical Trial Eligibility Overview. Trial Name: NCT05643573 — Phase 3
Atrial Fibrillation Research Study Groups: Asundexian, Apixaban
Atrial Fibrillation Clinical Trial 2023: Apixaban Highlights & Side Effects. Trial Name: NCT05643573 — Phase 3
Apixaban (Anticoagulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05643573 — Phase 3
Atrial Fibrillation Patient Testimony for trial: Trial Name: NCT05643573 — Phase 3
~5234 spots leftby Oct 2025