JRCT ID: jRCT2041220133
Registered date:01/02/2023
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
Basic Information
Recruitment status | Not Recruiting |
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Health condition(s) or Problem(s) studied | Acute non-cardioembolic ischemic stroke or high-risk transient ischemic attack |
Date of first enrollment | 30/01/2023 |
Target sample size | 12300 |
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,India,Japan,Israel,Japan,Italy,Japan,Kazakhstan,Japan,Latvia,Japan,Lithuania,Japan,Malaysia,Japan,Netherlands,Japan,Norway,Japan,Poland,Japan,Portugal,Japan,Slovakia,Japan,South Korea,Japan,Spain,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) |
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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 |
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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 |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | NCT05686070 |
Contact
Public contact | |
Name | contact Dedicated |
Address | 2-4-9 Umeda, Kita-ku, Osaka Osaka Japan 530-0001 |
Telephone | +81-6-6133-6363 |
byl_ct_contact@bayer.com | |
Affiliation | Bayer Yakuhin, Ltd |
Scientific contact | |
Name | Myoishi Masashi |
Address | 2-4-9 Umeda, Kita-ku, Osaka Osaka Japan 530-0001 |
Telephone | +81-6-6133-6363 |
byl_ct_contact@bayer.com | |
Affiliation | Bayer Yakuhin, Ltd |