DLBS1033 for the Treatment of Acute Ischemic Stroke

• Status: Terminated
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, randomized, double-blind, and controlled clinical study to investigate the effects of DLBS1033 in conjunction with standard therapy compared to standard therapy alone in acute ischemic stroke patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dexa Medica Group

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).