Effect of Dipeptidyl-4 Inhibitors in Reducing Stroke Severity, From HIRA Database

July 19, 2023 updated by: Seong-Joon Lee, Ajou University School of Medicine

Effect of Dipeptidyl-4 Inhibitors in Reducing Stroke Severity, From the Health Insurance Review and Assessment Service Database

The goal of this observational study is to compare severity and mortality rates of acute cerebral infarction(requiring thrombolysis or endovascular recanalization) depending on the type of oral antidiabetic drug taken before the onset of cerebral infarction.

Researchers will compare the group that used DPP-4 inhibitors as anti-diabetic drugs before cerebral infarction and the group that did not use them to see the effect of DPP-4 inhibitors in reducing severity of cerebral infarction.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a retrospective study to see the effects of reducing the severity of cerebral infarction(requiring thrombolysis or endovascular recanalization) of DPP-4 inhibitors by comparing the survival rate after acute cerebral infarction hospitalization, discharge rate to home, and medical cost.

A. Severity of cerebral infarction and poor prognosis is mainly associated with hyperglycemia caused by diabetes, which increases the Infarction volume and hemorrhagic trasformation.

B. However, the effect of loergin blood glucose on reducing the Infarction volume and improving prognosis of cerebral infarction has not been proven.

C. Preclinical studies have demonstrated a anti-stroke effect that reduces the Infarction volume using certain anti-diabetic drugs.

D. Therefore, there is a possibility that certain anti-diabetic drugs may reduce the severity of cerebral infarction as a class effect in addition to the effect of blood sugar control.

E. This is particularly likely to exist in the DPP-4 inhibitor family identified through preclinical studies.

Study Type

Observational

Enrollment (Estimated)

22119

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 Contact Backup

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This is a retrospective study using the Health Insurance Review and Assessment Service (HIRA) database in Korea.

In this database, patients with acute cerebral infarction who underwent thrombolysis(intravenous thrombolysis) or endovascular recanalization (intraarterial thrombectomy) between 2014 and 2021 is included.

Description

Inclusion Criteria:

  • Patients with acute cerebral infarction who underwent thrombolysis or endovascular recanalization in Korea between 2014 and 2021
  • Those who have been previously diagnosed with diabetes and are taking oral anti-diabetic drugs

  • Adult (over 19 years of age)

    • The definition of antidiabetic drug use is defined as a case in which an antidiabetic drug was prescribed for at least 2 months before stroke and the duration of treatment for stroke coincided with the prescribed duration of the drug.

Exclusion Criteria:

  • Patients taking insulin to control diabetes

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
DPP4i
used DPP-4 inhibitors as anti-diabetic drugs before cerebral infarction(requiring thrombolysis or endovascular recanalization) Combination therpay is acceptable.
Drug: Dipeptidyl peptidase-4 inhibitor
The definition of antidiabetic drug use is defined as a case in which an antidiabetic drug was prescribed for at least 2 months before stroke and the duration of treatment for stroke coincided with the prescribed duration of the drug.
Other Names:
  • A10BH07
  • EVOGLIPTIN
  • Suganon Tab
except DPP4i
patients that did not use DPP-4 inhibitors as anti-diabetic drugs before cerebral infarction(requiring thrombolysis or endovascular recanalization)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-year survival rate
Time Frame: Check the data one year after the onset of stroke.
The survival rates of the DPP-4 inhibitor group and the non-use group are compared 1 year after the onset of severe stroke.
Check the data one year after the onset of stroke.
90-day survival rate
Time Frame: Check the data 90-day after the onset of stroke.
The survival rates of the DPP-4 inhibitor group and the non-use group are compared 90-day after the onset of severe stroke.
Check the data 90-day after the onset of stroke.
re-hospitalization
Time Frame: 1 year after discharge the stroke treatment.
The re-hospitalization rates of the DPP-4 inhibitor group and the non-use group are compared after the onset of severe stroke.
1 year after discharge the stroke treatment.
frequency of cerebral hemorrhage
Time Frame: Hospitalization period and 1 year after discharge the stroke treatment.
The frequency of cerebral hemorrhage rates of the DPP-4 inhibitor group and the non-use group are compared after the onset of severe stroke.
Hospitalization period and 1 year after discharge the stroke treatment.
Rate of Intensive care unit treatment
Time Frame: Hospitalization period is expected to be up to three months. It is not possible to accurately estimate the period of hospitalization due to severe stroke.
The Intensive care unit treatment rate of the DPP-4 inhibitor group and the non-use group are compared.
Hospitalization period is expected to be up to three months. It is not possible to accurately estimate the period of hospitalization due to severe stroke.
Duration of Intensive care unit
Time Frame: Hospitalization period is expected to be up to three months. It is not possible to accurately estimate the period of hospitalization due to severe stroke.
The duration of Intensive care unit of the DPP-4 inhibitor group and the non-use group are compared.
Hospitalization period is expected to be up to three months. It is not possible to accurately estimate the period of hospitalization due to severe stroke.
Rate of Stroke care unit treatment
Time Frame: Hospitalization period is expected to be up to three months. It is not possible to accurately estimate the period of hospitalization due to severe stroke.
The Stroke care unit treatment rate of the DPP-4 inhibitor group and the non-use group are compared.
Hospitalization period is expected to be up to three months. It is not possible to accurately estimate the period of hospitalization due to severe stroke.
Duration of Stroke care unit
Time Frame: Hospitalization period is expected to be up to three months. It is not possible to accurately estimate the period of hospitalization due to severe stroke.
The duration of Stroke care unit of the DPP-4 inhibitor group and the non-use group are compared.
Hospitalization period is expected to be up to three months. It is not possible to accurately estimate the period of hospitalization due to severe stroke.
tracheal intubation period
Time Frame: Hospitalization period is expected to be up to three months. It is not possible to accurately estimate the period of hospitalization due to severe stroke.
The tracheal intubation period of the DPP-4 inhibitor group and the non-use group are compared.
Hospitalization period is expected to be up to three months. It is not possible to accurately estimate the period of hospitalization due to severe stroke.
total hospitalization days
Time Frame: Hospitalization period is expected to be up to three months. It is not possible to accurately estimate the period of hospitalization due to severe stroke.
The total hospitalization days of the DPP-4 inhibitor group and the non-use group are compared.
Hospitalization period is expected to be up to three months. It is not possible to accurately estimate the period of hospitalization due to severe stroke.
medical expenses incurred at the time of hospitalization
Time Frame: Hospitalization period is expected to be up to three months. It is not possible to accurately estimate the period of hospitalization due to severe stroke.
The medical expenses incurred at the time of hospitalization of the DPP-4 inhibitor group and the non-use group are compared.
Hospitalization period is expected to be up to three months. It is not possible to accurately estimate the period of hospitalization due to severe stroke.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Home discharge rate
Time Frame: At the end of discharge from stroke treatment.
The Home discharge rate of the DPP-4 inhibitor group and the non-use group are compared.
At the end of discharge from stroke treatment.
medical expenses after discharge from hospital
Time Frame: 1 year after discharge the stroke treatment.
The medical expenses after discharge from hospital of the DPP-4 inhibitor group and the non-use group are compared.
1 year after discharge the stroke treatment.

Collaborators and Investigators

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

Sponsor

Ajou University School of Medicine

Collaborators

Dong-A ST Co., Ltd.

Investigators

  • Principal Investigator: DukYong Yoon, MD., PhD., Department of Biomedical Systems Informatics,Yonsei University College of Medicine,Yongin,SouthKorea
  • Principal Investigator: Seong-Joon Lee, MD., PhD., Department of Neurology, Ajou University School of Medicine, Suwon, South Korea

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 (Estimated)

August 1, 2023

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

March 8, 2023

First Submitted That Met QC Criteria

April 5, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AJOUIRB-EX-2023-089

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Ajou University Hospital's IRB(Institutional Review Board) sends IRB approval documents to HIRA and conducts research with anonymized data after request.

Data collected during the research process will be stored for 3 years and then properly disposed of in accordance with relevant laws.

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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