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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
OCEANIC-AF Trial Summary
This trial is researching a new type of anticoagulant to improve the standard of care for people with atrial fibrillation, reducing the risk of stroke and embolism, and minimizing the risk of bleeding.
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.Check my eligibility
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.See study design
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.
OCEANIC-AF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 34 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 34 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to first occurrence of ISTH major bleeding
Time to first occurrence of composite of stroke or systemic embolism
Time to first occurrence of composite of stroke, systemic embolism, or ISTH major bleeding
Secondary outcome measures
Time to first occurrence of CV death
Time to first occurrence of all-cause mortality
Time to first occurrence of clinically relevant non-major bleeding
+10 moreOCEANIC-AF 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
Find a Location
Who is running the clinical trial?
BayerLead Sponsor
2,237 Previous Clinical Trials
25,312,148 Total Patients Enrolled
95 Trials studying Atrial Fibrillation
2,256,170 Patients Enrolled for Atrial Fibrillation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have atrial fibrillation that can be reversed.You have a mechanical heart valve.You have a significant blockage in your mitral valve.You need to take blood thinners for a condition other than atrial fibrillation.You have a heart condition called atrial fibrillation and need to take medication to prevent blood clots.You have a specific score based on your age, sex, and medical history that might increase your risk for certain health issues.You have a specific score based on certain health factors that may affect your eligibility for the study.You have a heart condition called atrial fibrillation and need to take a blood-thinning medicine for an indefinite period.
Research Study Groups:
This trial has the following groups:- Group 1: Asundexian
- Group 2: Apixaban
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.
Atrial Fibrillation Patient Testimony for trial: Trial Name: NCT05643573 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available vacancies within this trial for participants?
"According to clinicaltrials.gov, the trial is currently enrolling patients. This research was opened on December 5th 2022 and modified more recently, on December 8th of the same year."
Answered by AI
Is Asundexian a risk-free pharmaceutical for clients?
"According to our team at Power, Asundexian can be rated a 3 in terms of safety as it is currently being studied during Phase 3. This means that efficacy has already been established and multiple rounds have demonstrated its security."
Answered by AI
How many people have enrolled for this research project?
"Affirmative. According to the details provided on clinicaltrials.gov, this trial is actively looking for participants and was first released on December 5th 2022 with a subsequent update made on December 8th 2022. The study aims to recruit 18000 individuals from 100 different medical centres across the country."
Answered by AI
What is the geographical distribution of this experiment?
"This clinical trial is recruiting a total of 100 patients, with enrolment sites spanning from Mobile Heart Specialists in Alabama to Hoag Memorial Hospital Presbyterian in California."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
British Columbia
California
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+
1
0
What site did they apply to?
Baptist Hosptial East
Louisiana Heart Center Research - Slidell
NYU Langone Medical Associates - Chelsea
Other
What questions have other patients asked about this trial?
Does the trial cover the cost of either medication?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
To reduce cost of medication. Interest in Afib new medical drugs and techniques.
PatientReceived no prior treatments
I have read about this drug and I have high hopes it could help me. I have had 2 heart attacks and have tried 3 meds to control my afib.
PatientReceived 2+ prior treatments
I just want to help further medical treatment, and need some extra income.
PatientReceived no prior treatments
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