Stroke, Ischemic
Conditions
Keywords
Reperfusion, Lipoic acid, Stroke
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.
Interventions
DRUGalpha lipoic acid
alpha lipoic acid treatment
DRUGSaline
No alpha lipoic acid treatment
Sponsors
Chosun University Hospital
Chonbuk National University Hospital
Wonkwang University Hospital
Chonnam National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Number of participants with major bleeding | 3 months | Intracranial and extracranial bleeding within 3 months |
| Number of participants with recurrence | 3 months | Recurrent stroke within 3 months |
| Rate of mortality | 3 months | All cause of death within 3 months |
| Number of participants with BBB breakdown | 1 week | Hemorrhagic transformation within 1 week, Brain edema at 1 week after stroke |
Countries
South Korea
Contacts
Primary ContactKangho Choi, MD, PhD
Outcome results
None listed