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Not yet recruitingNCT05817097Updated Jul 20, 2023

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

An observational study in Cerebral Infarction, Infarction, Brain and Dipeptidyl-Peptidase IV Inhibitors, sponsored by Ajou University School of Medicine. Not yet recruiting. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2023-07-20.

Sponsored by Ajou University School of Medicine · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
22,119
Ages
19 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cerebral Infarction
  • Infarction, Brain
  • Dipeptidyl-Peptidase IV Inhibitors

Keywords

  • Dipeptidyl-Peptidase IV Inhibitors
  • Antidiabetic Drug
03

In context

Cerebral Infarction

219 studies on the registry are indexed under Cerebral Infarction; 46 are open to participants now.

This study's planned enrollment of 22,119 is above the median of 335 across 72 observational studies indexed under Cerebral Infarction.

Browse Cerebral Infarction studies →

Lead sponsor

Ajou University School of Medicine is the lead sponsor of 173 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients taking insulin to control diabetes
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
22,119 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • except DPP4i

    patients that did not use DPP-4 inhibitors as anti-diabetic drugs before cerebral infarction(requiring thrombolysis or endovascular recanalization)

Interventions

  • 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.

    Also known as: A10BH07, EVOGLIPTIN, Suganon Tab

06

What researchers measure

Primary outcomes

  1. 1-year survival rate

    The survival rates of the DPP-4 inhibitor group and the non-use group are compared 1 year after the onset of severe stroke.

    Time frame: Check the data one year after the onset of stroke.

  2. 90-day survival rate

    The survival rates of the DPP-4 inhibitor group and the non-use group are compared 90-day after the onset of severe stroke.

    Time frame: Check the data 90-day after the onset of stroke.

  3. re-hospitalization

    The re-hospitalization rates of the DPP-4 inhibitor group and the non-use group are compared after the onset of severe stroke.

    Time frame: 1 year after discharge the stroke treatment.

  4. frequency of cerebral hemorrhage

    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.

    Time frame: Hospitalization period and 1 year after discharge the stroke treatment.

  5. Rate of Intensive care unit treatment

    The Intensive care unit treatment rate of the DPP-4 inhibitor group and the non-use group are compared.

    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.

  6. Duration of Intensive care unit

    The duration of Intensive care unit of the DPP-4 inhibitor group and the non-use group are compared.

    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.

  7. Rate of Stroke care unit treatment

    The Stroke care unit treatment rate of the DPP-4 inhibitor group and the non-use group are compared.

    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.

  8. Duration of Stroke care unit

    The duration of Stroke care unit of the DPP-4 inhibitor group and the non-use group are compared.

    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.

  9. tracheal intubation period

    The tracheal intubation period of the DPP-4 inhibitor group and the non-use group are compared.

    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.

  10. total hospitalization days

    The total hospitalization days of the DPP-4 inhibitor group and the non-use group are compared.

    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.

  11. medical expenses incurred at the time of hospitalization

    The medical expenses incurred at the time of hospitalization of the DPP-4 inhibitor group and the non-use group are compared.

    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.

Secondary outcomes

  1. Home discharge rate

    The Home discharge rate of the DPP-4 inhibitor group and the non-use group are compared.

    Time frame: At the end of discharge from stroke treatment.

  2. medical expenses after discharge from hospital

    The medical expenses after discharge from hospital of the DPP-4 inhibitor group and the non-use group are compared.

    Time frame: 1 year after discharge the stroke treatment.

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Sinha B, Ghosal S. Meta-analyses of the effects of DPP-4 inhibitors, SGLT2 inhibitors and GLP1 receptor analogues on cardiovascular death, myocardial infarction, stroke and hospitalization for heart failure. Diabetes Res Clin Pract. 2019 Apr;150:8-16. doi: 10.1016/j.diabres.2019.02.014. Epub 2019 Feb 20. PubMed 30794833 ↗
  • Darsalia V, Ortsater H, Olverling A, Darlof E, Wolbert P, Nystrom T, Klein T, Sjoholm A, Patrone C. The DPP-4 inhibitor linagliptin counteracts stroke in the normal and diabetic mouse brain: a comparison with glimepiride. Diabetes. 2013 Apr;62(4):1289-96. doi: 10.2337/db12-0988. Epub 2012 Dec 3. PubMed 23209191 ↗
  • Lee SJ, Yoon BS, Hong JM, Joe EH, Lee JS. Effects of co-administration of metformin and evogliptin on cerebral infarct volume in the diabetic rat. Exp Neurol. 2022 Feb;348:113922. doi: 10.1016/j.expneurol.2021.113922. Epub 2021 Nov 12. PubMed 34780772 ↗
  • Johnston KC, Bruno A, Pauls Q, Hall CE, Barrett KM, Barsan W, Fansler A, Van de Bruinhorst K, Janis S, Durkalski-Mauldin VL; Neurological Emergencies Treatment Trials Network and the SHINE Trial Investigators. Intensive vs Standard Treatment of Hyperglycemia and Functional Outcome in Patients With Acute Ischemic Stroke: The SHINE Randomized Clinical Trial. JAMA. 2019 Jul 23;322(4):326-335. doi: 10.1001/jama.2019.9346. Erratum In: JAMA. 2019 Nov 5;322(17):1718. doi: 10.1001/jama.2019.16264. PubMed 31334795 ↗
  • Kim JY, Kang K, Kang J, Koo J, Kim DH, Kim BJ, Kim WJ, Kim EG, Kim JG, Kim JM, Kim JT, Kim C, Nah HW, Park KY, Park MS, Park JM, Park JH, Park TH, Park HK, Seo WK, Seo JH, Song TJ, Ahn SH, Oh MS, Oh HG, Yu S, Lee KJ, Lee KB, Lee K, Lee SH, Lee SJ, Jang MU, Chung JW, Cho YJ, Choi KH, Choi JC, Hong KS, Hwang YH, Kim SE, Lee JS, Choi J, Kim MS, Kim YJ, Seok J, Jang S, Han S, Han HW, Hong JH, Yun H, Lee J, Bae HJ. Executive Summary of Stroke Statistics in Korea 2018: A Report from the Epidemiology Research Council of the Korean Stroke Society. J Stroke. 2019 Jan;21(1):42-59. doi: 10.5853/jos.2018.03125. Epub 2018 Dec 18. PubMed 30558400 ↗
  • Park SH, Jeong HE, Oh IS, Hong SM, Yu SH, Lee CB, Shin JY. Cardiovascular safety of evogliptin in patients with type 2 diabetes: A nationwide cohort study. Diabetes Obes Metab. 2021 Jun;23(6):1232-1241. doi: 10.1111/dom.14330. Epub 2021 Feb 10. PubMed 33502058 ↗
  • Shim DH, Kim Y, Roh J, Kang J, Park KP, Cha JK, Baik SK, Kim Y. Hospital Volume Threshold Associated with Higher Survival after Endovascular Recanalization Therapy for Acute Ischemic Stroke. J Stroke. 2020 Jan;22(1):141-149. doi: 10.5853/jos.2019.00955. Epub 2020 Jan 31. PubMed 32027799 ↗

Individual participant data

Plan to share: No — 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05817097
Collaborators
Dong-A ST Co., Ltd.
Responsible party
Seong-Joon Lee (Assistant professor, Ajou University School of Medicine) — Principal investigator
First posted
Apr 18, 2023
Start date
Aug 2023 (estimated)
Primary completion
Dec 30, 2024 (estimated)
Completion
Dec 30, 2024 (estimated)
Last update
Jul 20, 2023

Study contacts

SooJung Kim
Contact
438104@gmail.com
82-31-219-6773
Seong-Joon Lee, MD., PhD.
Contact
editisan@gmail.com
82-31-219-4912
DukYong Yoon, MD., PhD.
principal investigator · Department of Biomedical Systems Informatics,Yonsei University College of Medicine,Yongin,SouthKorea
Seong-Joon Lee, MD., PhD.
principal investigator · Department of Neurology, Ajou University School of Medicine, Suwon, South Korea

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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