Vinpocetine Inhibits NF-κB-dependent Inflammation in Acute Ischemic Stroke
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- changes in lesion volume
研究概览
简要总结
Immunity and inflammation play critical roles in the pathogenesis of acute ischemic stroke. Therefore, immune intervention, as a new therapeutic strategy, is worthy of exploration. Here, investigators tested the inflammation modulator, vinpocetine, for its effect on the outcomes of stroke. For this multi-center study, investigators recruited 60 patients with anterior cerebral circulation occlusion and onset of stroke that had exceeded 4.5 hours but lasted less than 48 hours. These patients, after randomly division into two groups, received either standard management alone (controls) or standard management plus vinpocetine (30 mg per day intravenously for 14 consecutive days, Gedeon Richter Plc., Hungary).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •>18 years of age
- •Anterior-circulation ischemic stroke: All patients had symptoms of focal neurological deficits and simultaneous radiological evidence (magnetic resonance imaging, MRI) of an ischemic brain lesion
- •measurable neurological deficit (NIHSS > 5)
- •interval between symptom onset and admission more than 4.5 hours and less than 48 hours. That is, all patients we recruited were beyond the 4.5 hours of symptom onset and, therefore, past the accepted time-window for thrombolytic therapy
排除标准
- •hemorrhagic stroke and severe hemorrhage in other organs
- •other diseases of the central nervous system (CNS)
- •diabetes mellitus
- •tumor or hematological systemic diseases
- •any infection before acute ischemic stroke
- •concomitant use of antineoplastic or immune modulating therapies
- •contraindication to MRI
研究组 & 干预措施
vinpocetine group
Aspirin, 10mg, po and 30 mg of the vinpocetine by intravenous infusion once daily, for fourteen consecutive days
干预措施: vinpocetine (Drug)
vinpocetine group
Aspirin, 10mg, po and 30 mg of the vinpocetine by intravenous infusion once daily, for fourteen consecutive days
干预措施: Aspirin (Drug)
Control group
Patients will receive aspirin only.
干预措施: Aspirin (Drug)
结局指标
主要结局
changes in lesion volume
时间窗: lesion volume from baseline to day 7
changes in lesion volume from baseline (DWI) to day 7 (Flair)
extent of clinical improvement
时间窗: from baseline to day 7 and 14
extent of clinical improvement at day 7 and 14, as measured by the changes on the NIHSS score from baseline to day 7 and 14
brain inflammatory level
时间窗: day 7
brain inflammatory level (MRS) at day 7
次要结局
- cytotoxic edema(day 3)
- probability of excellent recovery(at day 90)
研究者
Junwei Hao
Professor
Tianjin Medical University General Hospital