A Non-interventional, Controlled, Open-label, Observational Registry Study to Investigate the Safety and Effectiveness of LUOTAI (Panax Notoginseng) Injectable and Soft Capsules in Patients With Acute Ischemic Stroke in Vietnam
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 364
- 试验地点
- 3
- 主要终点
- Primary Efficacy Endpoint: Modified Ranking Scale
研究概览
简要总结
Ischemic stroke occurs when an artery to the brain is blocked. If the artery remains blocked for more than a few minutes, the brain cells may die. This is why immediate medical treatment is critical.
Luotai® is the brand name of Panax notoginseng finished product. 2 kinds of formulation are available, the lyophilized powder for Injection and gelatin based soft capsule. They are being used for decreasing incidence of cerebral infarction or ischemic stroke.
This study will be conducted as an observational study, regarding the safety, effectiveness of Luotai treatment in acute ischemic stroke patients. This study will be carried out in approximately 360 patients with acute stroke in 6 hospitals in Vietnam - Bạch Mai Hospital, 108 Military Hospital, 103 Military Hospital, Trung Vuong Hospital, Phu Tho General Hospital, 115 Hospital.
STUDY PROCEDURES:
Participants will be enrolled in an unbiased manner (by consecutive sampling) and consecutive sampling method. The investigators will record participants' information required by the Case Report Form. The study which last for about 3 months, and in each of the visit, the information will be collected includes informed consent, demographic data, ischemic stroke assessment, concomitant medication, adverse reactions. A travel transportation allowance of VND 300,000 will be given for each visit.
Participants will receive Luotai and other medications according to the local hospital practice in accordance with the terms of the local marketing authorization in Vietnam. The recommended dosage of Luotai is: Luotai™ injectable lyophilized powder for consecutive 14 days, Luotai soft capsules for 65 days.
The participation of the study is fully voluntarily. Patients decide not to participate in the study will not be disadvantaged in any way. All collected information from participants is protected as confidential. The results of the study may be published in medical literature, but participants will not be identified.
This study does not include any procedure/test that there were not indicated according to local clinical practice. There is no specific associated risks or discomforts in this study related to the participation. The results of this research may guide in further understanding the Ischemic Stroke.
详细描述
STUDY TITLE:
A non-interventional, controlled, open-label (blinded assessor), prospective, multicenter, observational registry study to investigate the clinical practices, safety and effectiveness of LUOTAI (Panax notoginseng) injectable lyophilized powder and soft capsules in routine treatment of patients with acute ischemic stroke in Vietnam.
STUDY BACKGROUND Globally, cerebrovascular disease (stroke) is the second leading cause of death. According to the latest WHO data published in April 2011, stroke deaths in Vietnam reached 33,929 or 6.39% of total deaths. About 87% of strokes are caused by ischemia, mainly atherosclerotic cerebral infarction and transient ischemic attack.
Panax notoginseng is an important medicinal plant of the Araliacease family which has been used in China quite extensively as an herb since the end of the 19th century. Panax notoginseng traditionally believed can activate blood circulation and increase blood flow, dilating blood vessels, improves hemodynamics. Triterpene saponins are the bioactive constituents in Panax notoginseng. It contains high levels of notoginsenoside R1, ginsenosides Rb1, Rd and Rg1. Panax notoginseng has been reported to have anti-thrombotic effect via inhibiting thrombosis (inhibition rate: 92.1%). Inhibition of platelet aggregation and coagulation in rabbit's blood induced by ADP and arachidonic acid (up to 83.7%) was found. Increased t-PA activity was also found and coagulation time was prolonged.
Panax notoginseng was reported to have anti-inflammatory effects in atherosclerosis process, as well as inhibit inflammatory response in cerebral ischemia and infarction. Panax notoginseng antagonizes and attenuate delayed cerebral neuronal damage induced by blood reperfusion in cerebral ischemia. It was found to block neutrophil and macrophage activation, aggregation and infiltration induced by decreased releasing of serum interleukin-8. It can also reduce the quantity of Ca2+ in ischemic cerebral tissue, reduce cerebral edema and improve stroke symptoms.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged 18 or above
- •Clinical diagnosis of acute ischemic stroke
- •Patient's independence prior to stroke onset (pre-morbid mRC of 0-1)
- •Reasonable expectation of successful follow-up (up to D90)
排除标准
- •Treatment with another investigational drug or other investigational interventions within 1 month prior to this study.
结局指标
主要结局
Primary Efficacy Endpoint: Modified Ranking Scale
时间窗: 3 months
Modified Rankin Scale (mRS) is an overall functional outcome measure, measuring stroke defect. Answer the test questions for 5-10 minutes. The score range is 7 points with a score of 0 for the absence of sequelae and the worst possible score is 6. 0 - No symptoms. 1. - No significant disability. Able to carry out all usual activities, despite some symptoms. 2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. - Moderate disability. Requires some help, but able to walk unassisted. 4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. - Dead. Primary Efficacy Endpoint defined as "Categorical shift in mRS score at 3 months (ordinal logistic regression analysis of the mRS on Day 90)".
次要结局
- Cognitive status (MoCA)(on Day 90)
- mRC Proportion(on Day 90)
- NIHSS(on Day 0, 7, 90)
- ARAT Score(on Day 90)