A study to learn more about asundexian (also called BAY2433334) for prevention of ischemic stroke in male and female participants aged 18 years and older who already had such a stroke due to a blood clot that formed outside the heart and travelled to the brain, or temporary stroke-like symptoms

JRCT ID: jRCT2041220133

Registered date:01/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Acute non-cardioembolic ischemic stroke or high-risk transient ischemic attack
• Date of first enrollment: 26/01/2023
• Target sample size: 9300
• Countries of recruitment: Argentina,Japan,Australia,Japan,Austria,Japan,Belgium,Japan,Brazil,Japan,Bulgaria,Japan,Canada,Japan,China,Japan,Colombia,Japan,Czechia,Japan,Denmark,Japan,Finland,Japan,France,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,Israel,Japan,Italy,Japan,South Korea,Japan,Latvia,Japan,Lithuania,Japan,Malaysia,Japan,Netherlands,Japan,Norway,Japan,Poland,Japan,Portugal,Japan,Romania,Japan,Slovakia,Japan,Spain,Japan,Sweden,Japan
• Study type: Interventional

Intervention(s)

Asundexian (Experimental, BAY 2433334): Participants will receive asundexian (once a day, oral)
Placebo (Placebo Comparator):Participants will receive placebo to asundexian (once a day, oral)

Outcome(s)

Primary Outcome

- Time to first occurrence of ischemicstroke (Timeframe:Up to 31 months)
- Time to first occurrence of ISTH major bleeding (Timeframe:Up to 31 months)

Secondary Outcome

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

Key inclusion & exclusion criteria

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

Include criteria

- Participants must be >= 18 years of age
- Acute non-cardioembolic stroke or high-risk TIA
- Systemic or cerebrovascular atherosclerosis or acute non-lacunar infarct

Exclude criteria

- Ischemic stroke =< 7 days before the index stroke event
- Index stroke following procedures or strokes due to other rare causes
- History of atrial fibrillation/flutter, left ventricular thrombus, mechanic valve or other cardioembolic source of stroke requiring anticoagulation

Related Information

• Primary Sponsor: Masashi Myoishi
• Secondary ID(s): NCT05686070