NCT05817097

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
22,119

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2023

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

First Submitted

Initial submission to the registry

March 8, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

1.4 years

First QC Date

March 8, 2023

Last Update Submit

July 19, 2023

Conditions

Keywords

Dipeptidyl-Peptidase IV InhibitorsAntidiabetic Drug

Outcome Measures

Primary Outcomes (11)

  • 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.

    Check the data one year after the onset of stroke.

  • 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.

    Check the data 90-day after the onset of stroke.

  • 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.

    1 year after discharge the stroke treatment.

  • 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.

    Hospitalization period and 1 year after discharge the stroke treatment.

  • 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.

    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

    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

    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

    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

    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

    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

    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 Outcomes (2)

  • Home discharge rate

    At the end of discharge from stroke treatment.

  • medical expenses after discharge from hospital

    1 year after discharge the stroke treatment.

Study Arms (2)

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
DPP4i

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients taking insulin to control diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Cerebral InfarctionBrain Infarction

Interventions

Dipeptidyl-Peptidase IV Inhibitors4-(3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(tert-butoxymethyl)piperazin-2-one

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesStrokeVascular DiseasesCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Protease InhibitorsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesHypoglycemic AgentsPhysiological Effects of Drugs

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Seong-Joon Lee, MD., PhD.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

March 8, 2023

First Posted

April 18, 2023

Study Start

August 1, 2023

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

July 20, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

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.