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

Chonnam National University Hospital120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Stroke, Ischemic

Interventions

alpha lipoic acidDRUG

alpha lipoic acid treatment

SalineDRUG

No alpha lipoic acid treatment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Chonnam National University Hospital

Gwangju, South Korea

RECRUITING

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Central Contacts

Kangho Choi, MD, PhD

CONTACT

82-62-220-6137 ckhchoikang@hanmail.net

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.