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

Sponsor
Ajou University School of Medicine (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05817097
Collaborator
Dong-A ST Co., Ltd. (Industry)
22,119
21

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dipeptidyl peptidase-4 inhibitor

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.

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

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

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

  4. 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.

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

Study Design

Study Type:
Observational
Anticipated Enrollment :
22119 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Effect of Dipeptidyl-4 Inhibitors in Reducing Stroke Severity, From the Health Insurance Review and Assessment Service Database
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Dec 30, 2024
Anticipated Study Completion Date :
Dec 30, 2024

Arms and Interventions

Arm 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)

    Outcome Measures

    Primary Outcome Measures

    1. 1-year survival rate [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.

    2. 90-day survival rate [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.

    3. re-hospitalization [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.

    4. frequency of cerebral hemorrhage [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.

    5. Rate of Intensive care unit treatment [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.

    6. Duration of Intensive care unit [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.

    7. Rate of Stroke care unit treatment [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.

    8. Duration of Stroke care unit [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.

    9. tracheal intubation period [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.

    10. total hospitalization days [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.

    11. medical expenses incurred at the time of hospitalization [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.

    Secondary Outcome Measures

    1. Home discharge rate [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.

    2. medical expenses after discharge from hospital [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Ajou University School of Medicine
    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Seong-Joon Lee, Assistant professor, Ajou University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT05817097
    Other Study ID Numbers:
    • AJOUIRB-EX-2023-089
    First Posted:
    Apr 18, 2023
    Last Update Posted:
    Apr 18, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Seong-Joon Lee, Assistant professor, Ajou University School of Medicine
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 18, 2023