Ischemic Stroke
Conditions
Brief summary
A study to Evaluate the Efficacy and Safety of Renexin CR in patients with Acute Non-cardioembolic Ischemic Stroke
Interventions
Renexin CR 200/160mg will be added to Aspirin 100mg
DRUGPlavix 75mg
Plavix 75mg will be added to Aspirin 100mg
Sponsors
SK Chemicals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1\) Patients identified as acute non-cardioembolic ischemic stroke on MRI within 72 hours of onset of symptoms of cerebral infarction.
Exclusion criteria
1. Patients with active cancer; vascular malformation, abscess, or other major non-ischemic brain disease (e.g., multiple sclerosis). 2. With a modified Rankin Score (mRS) of 3 or higher before onset. 3. Underwent intravenous thrombolytic therapy (intravenous rtPA) or mechanical thrombectomy within 24 hours of the screening visit. 4. History of hypersensitivity to IP or components 5. Not suitable for aspirin administration at the discretion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - 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 |
Countries
South Korea
Outcome results
None listed