A Study to Evaluate the Efficacy and Safety of Renexin CR in Patients With Acute Non-cardioembolic Ischemic Stroke
- Registration Number
- NCT05445895
- Lead Sponsor
- SK Chemicals Co., Ltd.
- Brief Summary
A study to Evaluate the Efficacy and Safety of Renexin CR in patients with Acute Non-cardioembolic Ischemic Stroke
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
- Patients identified as acute non-cardioembolic ischemic stroke on MRI within 72 hours of onset of symptoms of cerebral infarction.
Exclusion Criteria
- Patients with active cancer; vascular malformation, abscess, or other major non-ischemic brain disease (e.g., multiple sclerosis).
- With a modified Rankin Score (mRS) of 3 or higher before onset.
- Underwent intravenous thrombolytic therapy (intravenous rtPA) or mechanical thrombectomy within 24 hours of the screening visit.
- History of hypersensitivity to IP or components
- Not suitable for aspirin administration at the discretion of the investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Clopidogrel 75mg Plavix 75mg Plavix 75mg will be added to Aspirin 100mg Renexin CR 200/160mg Renexin CR 200/160mg Renexin CR 200/160mg will be added to Aspirin 100mg
- Primary Outcome Measures
Name Time Method - The sum of the rate of neurological deterioration during hospitalization after taking the IP and the rate of stroke up to 90 days up to 90 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of