Impact of Lipoic Acid Use on Stroke Outcome After Reperfusion Therapy in Patients With Diabetes (IMPORTANT)
- Registration Number
- NCT04041167
- Lead Sponsor
- Chonnam National University Hospital
- Brief Summary
This study aims to investigate the effectiveness and safety of alpha-lipoic acid in patients with diabetes and ischemic stroke treated with reperfusion therapy.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Normal saline Saline All patients will receive intravenous normal saline within 24 hours of symptom onset. Alpha lipoic acid 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.
- Primary Outcome Measures
Name Time Method Number of participants with functional independence 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.
- Secondary Outcome Measures
Name Time Method Rate of mortality 3 months All cause of death within 3 months
Number of participants with recurrence 3 months Recurrent stroke within 3 months
Number of participants with BBB breakdown 1 week Hemorrhagic transformation within 1 week, Brain edema at 1 week after stroke
Number of participants with major bleeding 3 months Intracranial and extracranial bleeding within 3 months
Number of participants with early neurological deterioration 2 weeks early neurological deterioration is defined as an increase of ≥1 point in motor power or an increase of ≥2 points in the total NIHSS score within 2 weeks
Trial Locations
- Locations (1)
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of