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

Cerebral Infarction Clinical Trial

Official title:

Effect of Dipeptidyl-4 Inhibitors in Reducing Stroke Severity, From the Health Insurance Review and Assessment Service Database

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05817097
• Other study ID #: AJOUIRB-EX-2023-089
• Status: Not yet recruiting
• Start date: August 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: July 2023
• Source: Ajou University School of Medicine
• Contact: SooJung Kim
• Phone: 82-31-219-6773
• Email: 438104[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22119
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ajou University School of Medicine	Dong-A ST Co., Ltd.

References & Publications (7)

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. — View 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 Hyperglyce — View 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 — View 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. — View 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. — View 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. E — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	Home discharge rate	The Home discharge rate of the DPP-4 inhibitor group and the non-use group are compared.	At the end of discharge from stroke treatment.
Secondary	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.	1 year after discharge the stroke treatment.