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

July 31, 2019 updated by: Kangho Choi, Chonnam National University Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Alpha lipoic acid
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
alpha lipoic acid treatment
Other Names:
  • thioctacid
Placebo Comparator: Normal saline
All patients will receive intravenous normal saline within 24 hours of symptom onset.
Drug: Saline
No alpha lipoic acid treatment
Other Names:
  • normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with functional independence
Time Frame: 3 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of mortality
Time Frame: 3 months
All cause of death within 3 months
3 months
Number of participants with BBB breakdown
Time Frame: 1 week
Hemorrhagic transformation within 1 week, Brain edema at 1 week after stroke
1 week
Number of participants with early neurological deterioration
Time Frame: 2 weeks
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
Number of participants with major bleeding
Time Frame: 3 months
Intracranial and extracranial bleeding within 3 months
3 months
Number of participants with recurrence
Time Frame: 3 months
Recurrent stroke within 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chonnam National University Hospital

Collaborators

Chonbuk National University Hospital
Wonkwang University Hospital
Chosun University Hospital

Investigators

  • Principal Investigator: Kangho Choi, MD, PhD, Chonnam National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Anticipated)

July 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

July 26, 2019

First Submitted That Met QC Criteria

July 31, 2019

First Posted (Actual)

August 1, 2019

Study Record Updates

Last Update Posted (Actual)

August 2, 2019

Last Update Submitted That Met QC Criteria

July 31, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMPORTANT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

IPD will be shared with other researchers.

IPD Sharing Time Frame

We will share the data for one year after the end of the study.

IPD Sharing Access Criteria

If a proposal for a joint research or a sub-study is proposed, the approval will be decided through a meeting of the committee.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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