Cerebral Infarction Clinical Trial
Official title:
Effect of Dipeptidyl-4 Inhibitors in Reducing Stroke Severity, From the Health Insurance Review and Assessment Service Database
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.
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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Ajou University School of Medicine | Dong-A ST Co., Ltd. |
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
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. |
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