Phase 3 study to investigate the efficacy and safety of the oral FXIa inhibitor asundexian
Research type
Research Study
Full title
A multicenter, international, randomized, placebo controlled, double-blind, parallel group and event driven Phase 3 study of the oral FXIa inhibitor asundexian (BAY 2433334) for the prevention of ischemic stroke in male and female participants aged 18 years and older after an acute non-cardioembolic ischemic stroke or high-risk TIA
IRAS ID
1006659
Contact name
Michael Devoy
Contact email
Sponsor organisation
Bayer AG
Eudract number
2022-001067-27
Clinicaltrials.gov Identifier
Research summary
The main objective of this study is to learn whether asundexian works better than placebo at preventing ischemic strokes in participants who recently had a non-cardioembolic ischemic stroke or high-risk transient ischemic attack when given in addition to standard of care therapy. Placebo looks like a medicine but does not have any medicine in it.
People who have already had a non-cardioembolic stroke due to a blood clot that formed outside the heart and travelled to the brain, are more likely to have another stroke. They are therefore treated preventively.
The study treatment asundexian is a new type of anticoagulant under development. Anticoagulants prevent the formation of blood clots by interfering with the process of blood clotting. Asundexian works by aiming to further improve the standard of care with regard to the risk of bleeding. Another aim of the study is to compare the occurrence of major bleeding events between the asundexian and the placebo group as major bleedings have a serious or even life-threatening impact on a person’s health.
The participants will either ingest asundexian or placebo tablets once a day for upto 3 to 31 months.Approximately every 3 months during the treatment period, either a phone call or a visit to the study site is scheduled on an alternating basis. Also, one visit before and up to two visits after the treatment period are planned.
During the study, the study team will:
• Check vital signs such as blood pressure and heart rate
•Examine the participants’ heart health using an electrocardiogram (ECG)
•Take blood samples
•Ask the participants questions about how they are feeling and what adverse events they are having
An adverse event is any medical problem that a participant has during a study which the doctors keep track of, irrespective if they think it is related or not to the study treatment. Further, the participants will be asked to complete a questionnaire on quality of life at certain time points in the study.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
22/EM/0261
Date of REC Opinion
19 Dec 2022
REC opinion
Further Information Favourable Opinion