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Asundexian for Stroke Prevention

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Intermountain Medical Center - Stroke, Murray, UTStroke Prevention+2 MoreAsundexian (BAY2433334) - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Stroke Prevention
  • Ischemic Stroke
  • Transient Ischemic Attack (TIA)

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

1
CSL300 (Phase 3)
2
Rivaroxaban 15 MG Oral Tablet [Xarelto]
2
Abelacimab (MAA868)

Study Objectives

2 Primary · 15 Secondary · Reporting Duration: Up to 31 months

Up to 31 months
Time to first occurrence of ISTH clinically relevant non-major bleeding
Time to first occurrence of ISTH major bleeding
Time to first occurrence of all strokes (ischemic and hemorrhagic)
Time to first occurrence of all-cause mortality
Time to first occurrence of composite of CV death, MI or stroke
Time to first occurrence of composite of CV death, all stroke, MI or ISTH major bleeding
Time to first occurrence of composite of ISTH major or clinically relevant non-major bleeding
Time to first occurrence of composite of all-cause mortality, MI or stroke
Time to first occurrence of composite of all-cause mortality, disabling stroke, fatal bleeding, symptomatic intracranial hemorrhage
Time to first occurrence of composite of ischemic stroke or ISTH major bleeding
Time to first occurrence of disabling stroke (mRS ≥3 at 90 days)
Time to first occurrence of fatal bleeding
Time to first occurrence of hemorrhagic stroke
Time to first occurrence of ischemic stroke
Time to first occurrence of minor bleeding
Time to first occurrence of symptomatic intracranial hemorrhage
Time to first occurrence of transient ischemic attack (TIA)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

2
CSL300 (Phase 3)
3
Rivaroxaban 15 MG Oral Tablet [Xarelto]
3
Abelacimab (MAA868)

Trial Design

2 Treatment Groups

Asundexian
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

9300 Total Participants · 2 Treatment Groups

Primary Treatment: Asundexian · Has Placebo Group · Phase 3

Asundexian
Drug
Experimental Group · 1 Intervention: Asundexian (BAY2433334) · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 31 months

Who is running the clinical trial?

BayerLead Sponsor
2,159 Previous Clinical Trials
23,868,214 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You recently had a stroke or a mini-stroke that was not caused by a heart problem.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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