Asundexian for Atrial Fibrillation

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Atrial Fibrillation+1 MoreAsundexian (BAY2433334) - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

Researchers are looking for a better way to treat people with atrial fibrillation and prevent stroke or systemic embolism (blood clots travelling through the blood stream to plug another vessel). Atrial fibrillation is a condition of having irregular and often rapid heartbeat. It can lead to the formation of blood clots in the heart which can travel through the blood stream to plug another vessel, and like this lead to serious and life-threatening conditions, such as a stroke. A stroke occurs because the brain tissue beyond the blockage no longer receives nutrients and oxygen so that brain cells die. As strokes arising from atrial fibrillation can involve extensive areas of the brain, it is important to prevent them. Blood clots are formed in a process known as coagulation. Medications are already available to prevent the formation of blood clots. When taken by mouth (orally), they are known as oral anticoagulants (OACs) including apixaban. OACs decrease the risk of the above-mentioned serious and life-threatening conditions. The main side effect of OACs is an increase of the risk of bleeding. The study treatment asundexian is a new type of anticoagulant currently under development to provide further treatment options. The way it works, it aims to further improve the standard of care with regard to the risk of bleeding. The main purpose of this study is to collect more data about how well asundexian works to prevent stroke and systemic embolism and how safe it is compared to apixaban in people with atrial fibrillation and at high risk for stroke. To see how well the study treatment asundexian works researchers compare: how long asundexian works well and how long apixaban works well after the start of the treatment. Working well means that the treatments can prevent the following from happening: stroke and/or systemic embolism. The study will keep collecting data until a certain number of strokes or embolisms happen in the study. To see how safe asundexian is, the researchers will compare how often major bleedings occur after taking the study treatments asundexian and apixaban, respectively. Major bleedings are bleedings that have a serious or even life-threatening impact on a person's health. The study participants will be randomly (by chance) assigned to 1 of 2 treatment groups, A and B. Dependent on the treatment group, the participants will either take the study treatment asundexian by mouth once a day or apixaban by mouth twice a day for approximately 9 - 33 months. Each participant will be in the study for approximately 9 - 34 months. There will be visits to the study site every 3 to 6 months and up to 7 phone calls. Those participants who do not want or are unable to have visits to the study site may join the study remotely in selected countries. All visits for these participants will be done using electronic devices. During the study, the study team will: take blood samples do physical examinations examine heart health using an electrocardiogram (ECG) check vital signs such as blood pressure and heart rate do pregnancy tests ask the participants questions about their quality of life 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. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.

Eligible Conditions
  • Atrial Fibrillation
  • Stroke Prevention

Treatment Effectiveness

Effectiveness Progress

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

Study Objectives

3 Primary · 13 Secondary · Reporting Duration: Up to 34 months

Up to 34 months
Time to first occurrence of CV death
Time to first occurrence of ISTH major bleeding
Time to first occurrence of all-cause mortality
Time to first occurrence of clinically relevant non-major bleeding
Time to first occurrence of composite of CV death, stroke, or myocardial infarction
Time to first occurrence of composite of ISTH major or clinically relevant non-major bleeding
Time to first occurrence of composite of disabling stroke (mRS ≥ 3), critical bleeding, or all-cause mortality
Time to first occurrence of composite of ischemic stroke or systemic embolism
Time to first occurrence of composite of stroke or systemic embolism
Time to first occurrence of composite of stroke, systemic embolism, ISTH major bleeding, or all-cause mortality
Time to first occurrence of composite of stroke, systemic embolism, or ISTH major bleeding
Time to first occurrence of fatal bleeding
Time to first occurrence of hemorrhagic stroke
Time to first occurrence of intracranial hemorrhage
Time to first occurrence of ischemic stroke
Time to first occurrence of minor bleeding

Trial Safety

Safety Progress

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

Trial Design

2 Treatment Groups

Apixaban
1 of 2
Asundexian
1 of 2

Active Control

Experimental Treatment

18000 Total Participants · 2 Treatment Groups

Primary Treatment: Asundexian · Has Placebo Group · Phase 3

AsundexianExperimental Group · 2 Interventions: Asundexian (BAY2433334), Apixaban matching placebo · Intervention Types: Drug, Drug
ApixabanActiveComparator Group · 2 Interventions: Apixaban, Asundexian matching placebo · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apixaban matching placebo
2020
Completed Phase 2
~760

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 34 months

Who is running the clinical trial?

BayerLead Sponsor
2,150 Previous Clinical Trials
23,857,127 Total Patients Enrolled
95 Trials studying Atrial Fibrillation
2,191,898 Patients Enrolled for Atrial Fibrillation

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

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Who else is applying?

What state do they live in?
California40.0%
Georgia20.0%
Virginia20.0%
Other20.0%
What portion of applicants met pre-screening criteria?
Met criteria75.0%
Did not meet criteria25.0%
Why did patients apply to this trial?
  • "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"
How many prior treatments have patients received?
033.3%
233.3%
3+33.3%