Clinical trial NCT05817097: Effect of Dipeptidyl-4 Inhibitors in Reducing Stroke Severity, From HIRA Database
Official title: Effect of Dipeptidyl-4 Inhibitors in Reducing Stroke Severity, From the Health Insurance Review and Assessment Service Database
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cerebral Infarction
Infarction, Brain
Dipeptidyl-Peptidase IV Inhibitors
Keywords: Dipeptidyl-Peptidase IV Inhibitors
Antidiabetic Drug
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
Collaborators: name: Dong-A ST Co., Ltd.
First posted: 2023-04-18
Enrollment: 22119
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 1-year survival rate
timeFrame: Check the data one year after the onset of stroke.
measure: 90-day survival rate
timeFrame: Check the data 90-day after the onset of stroke.
measure: re-hospitalization
timeFrame: 1 year after discharge the stroke treatment.
measure: frequency of cerebral hemorrhage
timeFrame: Hospitalization period and 1 year after discharge the stroke treatment.
measure: Rate of Intensive care unit treatment
timeFrame: 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.
measure: Duration of Intensive care unit
timeFrame: 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.
measure: Rate of Stroke care unit treatment
timeFrame: 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.
measure: Duration of Stroke care unit
timeFrame: 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.
measure: tracheal intubation period
timeFrame: 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.
measure: total hospitalization days
timeFrame: 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.
measure: medical expenses incurred at the time of hospitalization
timeFrame: 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:
measure: Home discharge rate
timeFrame: At the end of discharge from stroke treatment.
measure: medical expenses after discharge from hospital
timeFrame: 1 year after discharge the stroke treatment.
Other outcomes:
Locations:
Study officials:
affiliation: Department of Biomedical Systems Informatics,Yonsei University College of Medicine,Yongin,SouthKorea
name: DukYong Yoon, MD., PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Neurology, Ajou University School of Medicine, Suwon, South Korea
name: Seong-Joon Lee, MD., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.