Impact of Lipoic Acid Use on Stroke Outcome After Reperfusion Therapy in Patients With Diabetes (IMPORTANT)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of Lipoic Acid Use on Stroke Outcome After Reperfusion Therapy in Patients With Diabetes

Conditions
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Stroke, Ischemic

Intervention / Treatment
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* Drug: alpha lipoic acid
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Alpha lipoic acid<br>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. | Drug: alpha lipoic acid<br>* alpha lipoic acid treatment<br>* Other names: thioctacid;|
| Placebo Comparator: Normal saline<br>All patients will receive intravenous normal saline within 24 hours of symptom onset. | Drug: Saline<br>* No alpha lipoic acid treatment<br>* Other names: normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with functional independence | 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of mortality | All cause of death within 3 months | 3 months | 
| Number of participants with BBB breakdown | Hemorrhagic transformation within 1 week, Brain edema at 1 week after stroke | 1 week | 
| Number of participants with early neurological deterioration | 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 | 2 weeks | 
| Number of participants with major bleeding | Intracranial and extracranial bleeding within 3 months | 3 months | 
| Number of participants with recurrence | Recurrent stroke within 3 months | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Reperfusion, Lipoic acid, Stroke