Effect of Dipeptidyl-4 Inhibitors in Reducing Stroke Severity, From HIRA Database
1 other identifier
observational
22,119
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2023
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2023
CompletedFirst Posted
Study publicly available on registry
April 18, 2023
CompletedStudy Start
First participant enrolled
August 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2024
CompletedJuly 20, 2023
July 1, 2023
1.4 years
March 8, 2023
July 19, 2023
Conditions
Keywords
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.
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.
Eligibility Criteria
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
- Ajou University School of Medicinelead
- Dong-A ST Co., Ltd.collaborator
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.
PMID: 30794833RESULTDarsalia 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.
PMID: 23209191RESULTLee 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.
PMID: 34780772RESULTJohnston 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.
PMID: 31334795RESULTKim 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.
PMID: 30558400RESULTPark 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.
PMID: 33502058RESULTShim 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.
PMID: 32027799RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
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.