CS-747S clinical pharmacology study
- Conditions
- Ischemic Stroke (exclude cardiac cerebral embolism)
- Registration Number
- JPRN-jRCT2080221011
- Lead Sponsor
- DAIICHISANKYO Co.,Ltd.
- Brief Summary
In patients with non-cardioembolic stroke, who switched from treatment with clopidogrel 75 mg, 4 week CS-747S treatment provided equivalent antiplatelet effects at 2.5 mg and greater effects at 3.75 mg. By CYP2C19 phenotypes, the antiplatelet effects of CS-747S were greater at 3.75 mg in IMs and PMs, and at 2.5 mg in PMs compared with clopidogrel 75 mg. CYP2C19 polymorphisms did not affect the plasma concentration of the active metabolite of CS-747S or its antiplatelet effects, compared to clopidogrel.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 133
Inclusion criteria
At the time of informed consent signature,
-The most recent ischemic stroke: 4 weeks or more
-Age: Between 20 and 74 years old
-Body weight: > 50kg (screening period)
-Patients on clopidogrel (75mg/day) for 2 weeks or more
(exclude patients with concomitant use of aspirin)
-Modified Rankin Scale grade 5 or more
-Cardiac cerebral embolism, or cardiovascular disease cause of cardiac cerebral embolism (atrial fibrillation, patent foramen ovale, etc.)
-Concomitant administration of clopidogrel and aspirin for secondary prevention of ACS etc.
-Have active or prior history of intracranial hemorrhage
-Have bleeding disorder or bleeding diathesis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method