Addition of DLBS1033 to Standard Therapy for Acute Ischemic Stroke Patients
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 80
- 试验地点
- 10
- 主要终点
- National Institutes of Health Stroke Scale (NIHSS)
研究概览
简要总结
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. It is hypothesized that the improvement in functional outcomes as measured by NIHSS and BI as well as the improvement in haemostatic parameters as measured by thrombocyte aggregation test (TAT), fibrinogen, and d-dimer in DLBS group will be significantly greater than those in the control group.
详细描述
Subjects in this study will be screened consecutively and eligible subjects will be randomized into two groups and receive the investigational drug, DLBS1033 at a dose of 490 mg three times daily or its placebo in addition to standard therapy for 28-days course of therapy. Standard therapy used in this study will consist of: aspirin 80 mg, simvastatin 20 mg, and vitamin B complex.
After hospital admission and diagnosis, patient will be handled as per acute ischemic stroke management in each study site. Right after the patient is confirmed eligible to the study, the treatment(s) will be switched immediately into the study treatments. Clinical and laboratory examinations to evaluate the investigational drug's efficacy will be performed at baseline and 3, 7,14, and 28 days after study medication initiation; while safety examinations will be performed at the same time point, but 3 and 14 days after study medication initiation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 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-
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo
Placebo 3 x 1 tablet, given everyday for 28 days of study period
干预措施: Placebo (Drug)
DLBS1033
DLBS1033 enteric-coated tablet 3 x 490 mg daily, given everyday for 28 days of study period
干预措施: DLBS1033 (Drug)
结局指标
主要结局
National Institutes of Health Stroke Scale (NIHSS)
时间窗: 3, 7, 14, and 28 days after study medication
Change in functional outcomes as measured by NIHSS from its baseline value
Barthel Index (BI)
时间窗: 3, 7, 14, and 28 days after study medication
Change in functional outcomes as measured by BI from its baseline value
次要结局
- Fibrinogen level(3, 7, 14, and 28 days after study medication)
- Thrombocyte Aggregation Test (TAT)(3, 7, 14, and 28 days after study medication)
- D-dimer level(3, 7, 14, and 28 days after study medication)
- Liver function(7 and 28 days after study medication)
- Renal function(7 and 28 days after study medication)
- Routine hematology(7 and 28 days after study medication)
- Adverse events(1 - 28 days)