CS-747S PhaseIII trial (CVA)
- Conditions
- Ischemic cerebrovascular accident (except cardiogenic cerebral embolism and asymptomatic cerebral infarction)
- Registration Number
- JPRN-jRCT2080221542
- Lead Sponsor
- DAIICHISANKYO Co.,Ltd.
- Brief Summary
The non-inferiority of CS-747S to clopidogrel for the prevention of ischemic stroke, myocardial infarction, and other vascular death was not confirmed in patients with non-cardioembolic stroke. The incidences rate of cerebro-cardiovascular events and other efficacy events were generally similar to clopidogrel. The incidence rate of adverse events and bleeding events were comparable between CS-747S and clopidogrel, suggesting that there are no significant safety issues with CS-747S.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 3753
Patients with cerebral infarction that caused the last attack.
-The last attack : between 1 and 26 weeks prior to informed consent.
-Body weight: over 50 kg
-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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Rate of cerebrovascular and cardiovascular events.<br>The rate of cerebrovascular and cardiovascular events, and 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 confidence intervals of CS-747S group against clopidogrel bisulfate group are to be calculated. In addition, cumulative incidence of events is to be estimated by Kaplan-Meier method.
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>pharmacokinetics<br>pharmacodynamics<br>pharmacogenomics<br>Rate of bleeding event, etc.<br>The rate of bleeding events and their 95% confidence intervals are to be calculated.