Ischemic cerebrovascular accident (except cardiogenic cerebral embolism and asymptomatic cerebral infarction)
Conditions
Sponsors
DAIICHISANKYO Co.,Ltd.
Ube Industries,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patients with cerebral infarction that was suggested as the cause of the last attack. -The last attack: more than 4 weeks prior to informed consent. -Age >= 75 years old and/or body weight =< 50 kg
Exclusion criteria
Exclusion criteria: -Patients who need the dual antiplatelet therapy. -History of intracerebral hemorrhage. -Bleeding disorder or bleeding diathesis. -Patients with poorly-controlled blood pressure. -Severe hepatic disorder or kidney disturbance. -Body weight : less than 40kg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Frequency of clinically relevant bleeding events. The frequency and 95% confidence intervals of clinically relevant bleeding events which observed from the beginning of the administration of the study drug to the 14 days after the completion or discontinuation of study drug, are to be calculated by each group. | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy pharmacokinetics pharmacodynamics pharmacogenomics Rate of efficacy endpoints, etc. The rate of efficacy endpoints in each group and their 95% confidence intervals are to be calculated. | — |
Countries
Japan
Outcome results
None listed