A study to learn how well the study treatment asundexian works and how safe it is compared to apixaban to prevent stroke or systemic embolism in people with irregular and often rapid heartbeat (atrial fibrillation), and at risk for stroke

JRCT ID: jRCT2061220080

Registered date:29/12/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Prevention of stroke or systemic embolism of Atrial fibrillation
• Date of first enrollment: 26/12/2022
• Target sample size: 18000
• Countries of recruitment: Argentina,Japan,Austria,Japan,Australia,Japan,Belgium,Japan,Bulgaria,Japan,Brazil,Japan,Canada,Japan,Switzerland,Japan,China,Japan,Colombia,Japan,Czechi,Japan,Germany,Japan,Denmark,Japan,Spain,Japan,Finland,Japan,France,Japan,United Kingdom,,Japan,Greece,Japan,Hungary,Japan,Israel,Japan,Italy,Japan,Korea,Japan,Republic of Lithuania,Japan,Latvia,Japan,Malaysia,Japan,Netherlands,Japan,Norway,Japan,Poland,Japan,Portugal,Japan,Romania,Japan
• Study type: Interventional

Intervention(s)

Asundexian (Experimental, BAY 2433334): Participants will receive asundexian (once a day) and apixaban matching placebo (twice a day).
Apixaban (Active Comparator): Participants will receive apixaban (5 mg or 2.5 mg, twice a day, according to product label) and asundexian matching placebo (once a day).

Outcome(s)

Primary Outcome

- Time to first occurrence of composite of stroke or systemic embolism (Timeframe:Up to 34 months)
- Time to first occurrence of ISTH major bleeding (Timeframe:Up to 34 months)
- Time to first occurrence of composite of stroke, systemic embolism, or ISTH major bleeding (Timeframe:Up to 34 months)

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- 18 years of age or older (at legal age of consent according to local legislation) at the time of signing the informed consent
- Atrial fibrillation documented by ECG evidence with an indication for indefinite treatment with an oral anticoagulant
- CHA2DS2-VASc score >= 3 if male or >= 4 if female,
OR
CHA2DS2-VASc score of 2 if male or 3 if female and enrichment criteria.

Exclude criteria

- Mechanical heart valve prosthesis
- Moderate-to-severe mitral stenosis at the time of inclusion into the study
- Atrial fibrillation only due to reversible cause
- Requirement for chronic anticoagulation for a different indication than AF

Related Information

• Primary Sponsor: Myoishi Masashi
• Secondary ID(s): NCT05643573