CS-747S PhaseIII trial (CVA)

CS-747S PhaseIII trial -Non-inferiority study of CS-747S versus clopidogrel bisulfate in patients with ischemic cerebrovascular accident.-

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221542

Enrollment

3600

Registered

2011-08-11

Start date

2011-09-11

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic cerebrovascular accident (except cardiogenic cerebral embolism and asymptomatic cerebral infarction)

Interventions

investigational material(s) Generic name etc : prasugrel hydrochloride INN of investigational material : prasugrel Therapeutic category code : 339 Other agents relating to blood and body fluides Dosag

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -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

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.

Design outcomes

Primary

Measure	Time frame
efficacy Rate of cerebrovascular and cardiovascular events. 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.	—

Measure

Time frame

efficacy Rate of cerebrovascular and cardiovascular events. 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

Measure	Time frame
safety efficacy pharmacokinetics pharmacodynamics pharmacogenomics 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

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026