DLBS1033 for the Treatment of Acute Ischemic Stroke


Phase 3 Results N/A

Eligibility Criteria

Inclusion Criteria

- Male or female subjects with age of 18-75 years .
- Has been diagnosed with acute ischemic stroke clinically confirmed by CT scan.
- Modified National Institutes of Health Stroke Scale (mNIHSS) score >= 5.
- 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 or current hemorrhagic stroke (within the last 3 months).
- Transient ischemic stroke (TIA).
- Patients with seizure at the onset of stroke.
- History of serious head injury within the last 3 months.
- History of major surgery within the last 3 months.
- Serious cardiovascular conditions, such as myocardial infarction, CHF grade III and IV (NYHA classification), aorta dissection, and atrial fibrillation within the last 6 months.
- Presence of severe renal or hepatic dysfunction
- Presence of acute or chronic infections.
- Thrombocytopenia (thrombocytes level < 150.000/ul).
- Patients with higher risks of bleeding.
- Uncontrolled hypertension (systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg).
- Random plasma glucose >= 200 mg/dL.
- Current or regular use of oral anticoagulants, antiplatelets other than study medication, and herbal medicines.
- Hypersensitive to the investigational product(s).