DLBS1033 for Acute Ischemic Stroke Patients "ADDLIST"


Phase 2/3 Results N/A

Eligibility Criteria

Inclusion Criteria

- Signed informed consent from the patients or patients' legally acceptable representatives (must be obtained before any trial related activities).
- Male or female subjects with age of 18-65 years at Screening.
- Patients clinically diagnosed having acute ischemic stroke attack and confirmed by CT scan.
- Patients with cerebral infarction subtypes of PACI or LACI as classified by Bamford criteria.
- Patients with moderate condition based on National Institutes of Health Stroke Scale (NIHSS) score of 5-15.
- Patients present at hospital and receiving first dose of study medication within 72 hours after the onset of the stroke symptoms.
- Able to take oral medication.

Exclusion Criteria

- For females of childbearing potential: pregnancy and lactation period.
- History of hemorrhagic stroke within the last 3 months.
- Patients with seizure at the onset of stroke or with regular medication for seizure/epilepsy.
- Current or regular use (within the last 1 month) of oral anticoagulants, antiplatelets other than study medication, and herbal medicines.
- Patients who have received tissue plasminogen activator (TPA) within 24 hours to Screening.
- History of serious head injury within the last 3 months.
- History of major surgery within the last 3 months.
- Recent serious cardiovascular conditions, such as myocardial infarction and heart atrial fibrillation as demonstrated by electrocardiography (ECG).
- History of congestive heart failure and aortic dissection.
- Presence of severe renal and hepatic dysfunction, defined as serum creatinine level > 3x upper limit of normal (ULN) or history of hemodialysis, and any of serum ALT, AST, Gamma-GT level of > 3x ULN, respectively.
- Presence of acute SIRS.
- Presence of chronic infections.
- Patients with higher risks of bleeding.
- Subjects with uncontrolled hypertension (systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg).
- Subjects with random plasma glucose ≥180 mg/dL and HbA1c ≥ 7.0% at Screening.
- Known or suspected hypersensitivity to the trial product or related products.
- Participation in any other clinical studies within 30 days prior to screening.