Impact of Lipoic Acid Use on Stroke Outcome After Reperfusion Therapy in Patients With Diabetes
试验速览
- 阶段
- 3 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Number of participants with functional independence
研究概览
简要总结
This study aims to investigate the effectiveness and safety of alpha-lipoic acid in patients with diabetes and ischemic stroke treated with reperfusion therapy.
详细描述
Despite significant advances in the prevention and treatment of stroke, it is still one of the leading causes of death and debilitating disease. Unfortunately, several neuroprotective strategies have failed in clinical trials. At present, it is reported that there are no pharmacological agents with putative neuroprotective actions that have demonstrated efficacy in improving outcomes after acute ischemic stroke (AIS) in humans. Previous stroke studies have confirmed that oxidative stress plays a vital role in stroke and in reperfusion following stroke. Therefore, the use of antioxidants could be a promising strategy for treating ischemia-reperfusion injury. Alpha-lipoic acid (aLA) is a potent antioxidant commonly used for the treatment of diabetic polyneuropathy (DPNP). The investigators previously demonstrated the neuroprotective and neurorestorative effects of aLA, mediated at least partially via insulin receptor activation, after cerebral ischemia in rats. Moreover, previous observational study of the investigators showed that patients with diabetes treated with aLA have better functional outcomes following AIS after reperfusion therapy than patients not using aLA.
Therefore, the investigators investigate whether patients with diabetes treated with aLA have better functional outcomes after AIS and reperfusion therapy than patients not treated with aLA in this prospective randomized trial.
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
- None
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
- •Patients with acute ischemic stroke within 6 hours of symptom onset
- •Patients with diabetes
- •Patients who underwent reperfusion therapy (Intravenous t-PA or endovascular thrombectomy)
排除标准
- •Pre-existing disability (Modified Rankin Scale >= 1)
- •Patients with severe renal disease (GFR <30 ml / min)
- •Patients whose survival period is expected to be less than 12 months due to serious diseases such as terminal cancer or liver failure
研究组 & 干预措施
Alpha lipoic acid
All patients will be assigned intravenous alpha lipoic acid 600mg within 24 hours of symptom onset. Patients will receive intravenous alpha lipoic acid 600mg/day for one week, followed by an oral pill of alpha lipoic acid 600mg/day for three months.
干预措施: alpha lipoic acid (Drug)
Normal saline
All patients will receive intravenous normal saline within 24 hours of symptom onset.
干预措施: Saline (Drug)
结局指标
主要结局
Number of participants with functional independence
时间窗: 3 months
The modified Rankin Scale (mRS) consists of 7 levels, ranging from perfect health without symptoms (mRS score 0) to death (mRS score 6). We defined functional independence as mRS scores of 0-2 at 3 months after stroke.
次要结局
- Rate of mortality(3 months)
- Number of participants with early neurological deterioration(2 weeks)
- Number of participants with recurrence(3 months)
- Number of participants with BBB breakdown(1 week)
- Number of participants with major bleeding(3 months)
研究者
Kangho Choi
Study Director
Chonnam National University Hospital