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

NCT ID: NCT05817097

Last Updated: 2023-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

22119 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-31

Study Completion Date

2024-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cerebral Infarction Infarction, Brain Dipeptidyl-Peptidase IV Inhibitors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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DPP4i

used DPP-4 inhibitors as anti-diabetic drugs before cerebral infarction(requiring thrombolysis or endovascular recanalization) Combination therpay is acceptable.

Dipeptidyl peptidase-4 inhibitor

Intervention Type DRUG

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.

except DPP4i

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

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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A10BH07 EVOGLIPTIN Suganon Tab

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dong-A ST Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Ajou University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Seong-Joon Lee

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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DukYong Yoon, MD., PhD.

Role: PRINCIPAL_INVESTIGATOR

Department of Biomedical Systems Informatics,Yonsei University College of Medicine,Yongin,SouthKorea

Seong-Joon Lee, MD., PhD.

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, Ajou University School of Medicine, Suwon, South Korea

Central Contacts

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SooJung Kim

Role: CONTACT

82-31-219-6773

Seong-Joon Lee, MD., PhD.

Role: CONTACT

82-31-219-4912

References

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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.

Reference Type RESULT
PMID: 30794833 (View on PubMed)

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.

Reference Type RESULT
PMID: 23209191 (View on PubMed)

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.

Reference Type RESULT
PMID: 34780772 (View on PubMed)

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.

Reference Type RESULT
PMID: 31334795 (View on PubMed)

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.

Reference Type RESULT
PMID: 30558400 (View on PubMed)

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.

Reference Type RESULT
PMID: 33502058 (View on PubMed)

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.

Reference Type RESULT
PMID: 32027799 (View on PubMed)

Other Identifiers

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AJOUIRB-EX-2023-089

Identifier Type: -

Identifier Source: org_study_id

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