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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

OCEANIC-STROKE Trial Summary

This trial tests whether a new anticoagulant drug is better than placebo to reduce ischemic stroke risk for people who recently had a non-cardioembolic stroke or temporary stroke-like symptoms. It also checks for major bleeding risks and quality of life.

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.Check my eligibility
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.See study design
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.

OCEANIC-STROKE Trial Timeline

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

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 ischemic stroke
Secondary outcome measures
Time to first occurrence of ISTH clinically relevant non-major bleeding
Time to first occurrence of all strokes (ischemic and hemorrhagic)
Time to first occurrence of all-cause mortality
+13 more

OCEANIC-STROKE 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

Find a Location

Who is running the clinical trial?

BayerLead Sponsor
2,238 Previous Clinical Trials
25,323,418 Total Patients Enrolled
2 Trials studying Transient Ischemic Attack
245 Patients Enrolled for Transient Ischemic Attack

Media Library

Asundexian (BAY2433334) (Anticoagulant) Clinical Trial Eligibility Overview. Trial Name: NCT05686070 — Phase 3
Transient Ischemic Attack Research Study Groups: Asundexian, Placebo
Transient Ischemic Attack Clinical Trial 2023: Asundexian (BAY2433334) Highlights & Side Effects. Trial Name: NCT05686070 — Phase 3
Asundexian (BAY2433334) (Anticoagulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05686070 — Phase 3
Transient Ischemic Attack Patient Testimony for trial: Trial Name: NCT05686070 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Asundexian received regulatory clearance from the FDA?

"Our team at Power assessed Asundexian's safety to be a 3 out of 3 due to data from clinical trials suggesting efficacy as well as several rounds of information validating the drug's security."

Answered by AI

How many administrative centers are responsible for the management of this research?

"HonorHealth in Scottsdale, Banner - University Medical Center Tucson in Tucson, and MemorialCare Health System in Long Beach are some of the sites performing this trial. Additionally, there are 65 other medical facilities participating across America."

Answered by AI

Are there currently any available positions for volunteers to participate in this trial?

"Data on clinicaltrials.gov shows that this particular medical investigation is not presently recruiting patients, despite having initially posted the trial on February 16th 2023 and most recently updating it on January 6th 2023. However, there are 1285 other studies actively seeking participants at this time."

Answered by AI

Who else is applying?

What state do they live in?
California
Nevada
Massachusetts
What site did they apply to?
Ronald Reagan UCLA Medical Center
Dartmouth Hitchock Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

To find answers how to prevent stokes. I have cadasil and 5 children with 50 percent chance of having it. I have had many Tia s.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study to Test Asundexian for Preventing a Stroke Caused by a Clot in Participants After an Acute Ischemic Stroke or After a High-risk Transient Ischemic Attack, a So-called Mini Stroke
2023. "A Study to Test Asundexian for Preventing a Stroke Caused by a Clot in Participants After an Acute Ischemic Stroke or After a High-risk Transient Ischemic Attack, a So-called Mini Stroke". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05686070.
All > Anterior Ischemic Optic Neuropathy
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