A Phase 3 interventional study of alpha lipoic acid and Saline in Stroke, Ischemic, sponsored by Chonnam National University Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-02.
Sponsored by Chonnam National University Hospital · Phase 3, Interventional, and Treatment
This study aims to investigate the effectiveness and safety of alpha-lipoic acid in patients with diabetes and ischemic stroke treated with reperfusion therapy.
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.
7,287 studies on the registry are indexed under Stroke; 2,006 are open to participants now.
This study's planned enrollment of 120 is above the median of 50 across 5,370 interventional studies indexed under Stroke.
Browse Stroke studies →Chonnam National University Hospital is the lead sponsor of 70 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
All patients will receive intravenous normal saline within 24 hours of symptom onset.
Drug: Saline
alpha lipoic acid treatment
Also known as: thioctacid
No alpha lipoic acid treatment
Also known as: normal saline
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.
Time frame: 3 months
Rate of mortality
All cause of death within 3 months
Time frame: 3 months
Number of participants with BBB breakdown
Hemorrhagic transformation within 1 week, Brain edema at 1 week after stroke
Time frame: 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
Time frame: 2 weeks
Number of participants with major bleeding
Intracranial and extracranial bleeding within 3 months
Time frame: 3 months
Number of participants with recurrence
Recurrent stroke within 3 months
Time frame: 3 months
Plan to share: Yes — IPD will be shared with other researchers.
Supporting information: Study protocol, Csr
This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Chonnam National University Hospital