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

Chonnam National University

Status and phase: Unknown; Phase 3

Conditions: Stroke, Ischemic

Treatments: Drug: alpha lipoic acid; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04041167

IMPORTANT

Details and patient eligibility

About

This study aims to investigate the effectiveness and safety of alpha-lipoic acid in patients with diabetes and ischemic stroke treated with reperfusion therapy.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups, including a placebo group

Alpha lipoic acid

Active Comparator group

Description:

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.

Treatment:

Drug: alpha lipoic acid

Normal saline

Placebo Comparator group

Description:

All patients will receive intravenous normal saline within 24 hours of symptom onset.

Treatment:

Drug: Saline