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

Stroke, Ischemic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04041167
• Other study ID #: IMPORTANT
• Status: Recruiting
• Phase: Phase 3
• Start date: August 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2019
• Source: Chonnam National University Hospital
• Contact: Kangho Choi, MD, PhD
• Phone: 82-62-220-6137
• Email: ckhchoikang[@]hanmail.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke
• Stroke, Ischemic

Intervention

Drug:
• alpha lipoic acid
alpha lipoic acid treatment
• Saline
No alpha lipoic acid treatment

Locations

Country	Name	City	State
Korea, Republic of	Chonnam National University Hospital	Gwangju

Sponsors (4)

Lead Sponsor	Collaborator
Chonnam National University Hospital	Chonbuk National University Hospital, Chosun University Hospital, Wonkwang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Secondary	Rate of mortality	All cause of death within 3 months	3 months
Secondary	Number of participants with BBB breakdown	Hemorrhagic transformation within 1 week, Brain edema at 1 week after stroke	1 week
Secondary	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	2 weeks
Secondary	Number of participants with major bleeding	Intracranial and extracranial bleeding within 3 months	3 months
Secondary	Number of participants with recurrence	Recurrent stroke within 3 months	3 months