Thrombotic Stroke
Conditions
Sponsors
DAIICHI SANKYO Co.,Ltd.
Ube Industries,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patients with evidence of infarct lesion(s) that may have caused the last episode of attack on head imaging -Patients whose subtype of stroke is either large-artery atherosclerosis or small-artery occlusion -Patients with at least one of the following risk factors i. to vi. i.Hypertension: Systolic and diastolic blood pressure of >=140 mmHg and >=90 mmHg. ii.Diabetes mellitus: HbA1c >=6.5%. iii.Chronic kidney disease: Estimated glomerular filtration rate (eGFR) =1+. iv.Dyslipidemia: LDL cholesterol >=120 mg/dL, HDL cholesterol =150 mg/dL. v.If none of the above numerical criteria i. to iv. are met in the presence of pharmacotherapy etc., patients having at least two risk factors from among hypertension, diabetes mellitus, chronic kidney disease, and dyslipidemia are eligible for the study. vi.History of stroke before the last episode of attack -Patients who are able to start treatment with the study drug during the period from 7 days to 26 weeks after onset of the last episode of ischemic attack
Exclusion criteria
Exclusion criteria: -Patients with symptomatic non-traumatic intracerebral hemorrhage or a known history thereof -Patients with bleeding or a high risk of bleeding -Patients scheduled to undergo cerebral revascularization for the latest ischemic attack -Patients with a severe hepatic disorder -Patients with severe renal disorder requiring dialysis therapy -Patients who have received clopidogrel sulfate for at least 22 days during the period from the last episode of ischemic attack to the start of treatment with the study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Rate of ischemic cerebrovascular and cardiovascular events (stroke, myocardial infarction, and death from other vascular cause) The rate of ischemic cerebrovascular and cardiovascular events, and their 95% confidence intervals of each groups, which observed from the beginning of the administration of the studying drug to the day after the completion or discontinuation of administration, are to be calculated. Then risk ratio and their 95% confidence intervals of CS-747S group against clopidogrel bisulfate group are to be calculated. | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy pharmacodynamics Rate of bleeding event, etc. The rate of bleeding events and their 95% confidence intervals are to be calculated. | — |
Countries
Japan
Outcome results
None listed