Clinical trial NCT04041167: Impact of Lipoic Acid Use on Stroke Outcome After Reperfusion Therapy in Patients With Diabetes (IMPORTANT)
Official title: Impact of Lipoic Acid Use on Stroke Outcome After Reperfusion Therapy in Patients With Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Stroke, Ischemic
Keywords: Reperfusion
Lipoic acid
Stroke
Lead sponsor: Chonnam National University Hospital
Sponsor class: OTHER
Collaborators: name: Chosun University Hospital
name: Chonbuk National University Hospital
name: Wonkwang University Hospital
First posted: 2019-08-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with functional independence
timeFrame: 3 months
Secondary outcomes:
measure: Rate of mortality
timeFrame: 3 months
measure: Number of participants with BBB breakdown
timeFrame: 1 week
measure: Number of participants with early neurological deterioration
timeFrame: 2 weeks
measure: Number of participants with major bleeding
timeFrame: 3 months
measure: Number of participants with recurrence
timeFrame: 3 months
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
Study officials:
affiliation: Chonnam National University Hospital
name: Kangho Choi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Choi KH, Park MS, Kim JT, Kim HS, Kim JH, Nam TS, Choi SM, Lee SH, Kim BC, Kim MK, Cho KH. Lipoic Acid Use and Functional Outcomes after Thrombolysis in Patients with Acute Ischemic Stroke and Diabetes. PLoS One. 2016 Sep 27;11(9):e0163484. doi: 10.1371/journal.pone.0163484. eCollection 2016.
citation: Choi KH, Park MS, Kim HS, Kim KT, Kim HS, Kim JT, Kim BC, Kim MK, Park JT, Cho KH. Alpha-lipoic acid treatment is neurorestorative and promotes functional recovery after stroke in rats. Mol Brain. 2015 Feb 11;8:9. doi: 10.1186/s13041-015-0101-6.