DLBS1033 for Acute Ischemic Stroke Patients "ADDLIST"

Recruiting

Phase 2/3 Results N/A

Update History

27 Nov '14
The eligibility criteria were updated.
New
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.
Old
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. - Patients or patients' legally acceptable representatives are able and willing to record adverse events in a diary. - Patients or patients' legally acceptable representatives have the ability to comply with the trial protocol. Exclusion Criteria: - For females of childbearing potential: pregnancy and lactation period. Patients must accept pregnancy tests during the trial if menstrual cycle is missed. Fertile patients must use effective contraception. - 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.
A location was updated in Semarang.
New
The overall status was updated to "Recruiting" at Neurology Department, Dr. Kariadi General Hospital.
A location was updated in Surabaya.
New
The overall status was updated to "Recruiting" at Stroke/Cerebrobascular Division, Neurology Department, Dr. Soetomo Hospital.