NCT04041167

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2018

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

August 2, 2019

Status Verified

July 1, 2019

Enrollment Period

3 years

First QC Date

July 26, 2019

Last Update Submit

July 31, 2019

Conditions

Stroke, Ischemic

Keywords

ReperfusionLipoic acidStroke

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Rate of mortality

    3 months

  • Number of participants with BBB breakdown

    1 week

  • Number of participants with early neurological deterioration

    2 weeks

  • Number of participants with major bleeding

    3 months

  • Number of participants with recurrence

    3 months

Study Arms (2)

Alpha lipoic acid

ACTIVE COMPARATOR

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

Normal saline

PLACEBO COMPARATOR

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

Drug: Saline

Interventions

alpha lipoic acidDRUG

alpha lipoic acid treatment

Also known as: thioctacid
Alpha lipoic acid
SalineDRUG

No alpha lipoic acid treatment

Also known as: normal saline
Normal saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chonnam National University Hospital

Gwangju, South Korea

RECRUITING

Related Publications (2)

  • 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.

    PMID: 27677185BACKGROUND

  • 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.

    PMID: 25761600BACKGROUND

MeSH Terms

Conditions

Ischemic StrokeStroke

Interventions

Thioctic AcidSodium ChlorideSaline Solution

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Carboxylic AcidsOrganic ChemicalsThiophenesSulfur CompoundsCoenzymesEnzymes and CoenzymesFatty AcidsLipidsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Kangho Choi, MD, PhD

    Chonnam National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kangho Choi, MD, PhD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Director

Study Record Dates

First Submitted

July 26, 2019

First Posted

August 1, 2019

Study Start

August 1, 2018

Primary Completion

July 31, 2021

Study Completion

December 31, 2021

Last Updated

August 2, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will share

IPD will be shared with other researchers.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
We will share the data for one year after the end of the study.
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.

Locations

KR(1)