Unique ID issued by UMIN | UMIN000039079 |
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Receipt number | R000044560 |
Scientific Title | Effect of empagliflozin 12 months after drug eluting stent implantation in type 2 diabetics with stable angina. |
Date of disclosure of the study information | 2020/01/08 |
Last modified on | 2020/01/08 02:51:54 |
Effect of empagliflozin 12 months after drug eluting stent implantation in type 2 diabetics with stable angina.
Effect of empagliflozin after drug eluting stent implantation in type 2 diabetics.
Effect of empagliflozin 12 months after drug eluting stent implantation in type 2 diabetics with stable angina.
Effect of empagliflozin after drug eluting stent implantation in type 2 diabetics.
Japan |
Ischemic heart disease, Type 2 diabetes mellitus
Cardiology | Endocrinology and Metabolism |
Others
NO
To assess the effect of empagliflozin on neointimal condition 12 months after drug eluting stent implantation using optical coherence tomography in patients with coronary artery disease.
Efficacy
Exploratory
Pragmatic
Not applicable
Comparison of neointimal tissue 12 months after drug eluting stent between diabetes patients with empagliflozin treatment and standard therapy; evaluated by optical coherence tomography.
The changes of ultrasound cardiography finding 12 months after intervention.
The changes of physical examination and laboratory findings including glucose (fasting glucose level, 1.5 AG, HbA1c),lipid parameter and inflamattory cytokine (hsCRP).
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
Additional treatment with empagliflozin in insuffiently controlled type 2 diabetes.
Intensive additional standard treatment without SGLT-2 inhibitor in insuffiently controlled type 2 diabetes.
18 | years-old | <= |
85 | years-old | >= |
Male and Female
Patients with objective evidence of myocardial ischemia who planned to receive percutaneous coronary intervention using drug eluting stent,and with type 2 diabetes with a HbA1c level >7.0% and a fasting plasma glucose level > 126 mg/dl.
Use of SGLT-2 inibitor at baseline
Use of insulin
Patients with moderate or severe chronic kidney disease (eGFR <45)
Patients with ST elevated myocardial infarction, chronic total occlusion, significant left main lesion, in-stent restenosis lesion
Endocrine and gastrointestinal disorders
Hepatic dysfunction (Child-Pugh score > 10)
Patients with malignancy
Patients with type 1 diabetes
30
1st name | Masao |
Middle name | |
Last name | Yamasaki |
NTT Medical center Tokyo
Department of Cardiology
141-0022
5-9-22 Higashigotanda, Shinagawa, Tokyo
+81-3-3448-6111
masayamlmt99@gmail.com
1st name | Takehiro |
Middle name | |
Last name | Hashikata |
NTT Medical Center Tokyo
Department of Cardiology
141-0022
5-9-22 Higashigotanda, Shinagawa, Tokyo
+81-3-3448-6111
t_hashikata@med.kitasato-u.ac.jp
Department of Cardiology, NTT Medical Center Tokyo
Department of Cardiology, NTT Medical Center Tokyo
Self funding
NTT Medical Center Tokyo
5-9-22 Higashigotanda, Shinagawa, Tokyo
+81-3-3448-6111
mutsumi.fujimoto@east.ntt.co.jp
NO
NTT東日本関東病院
2020 | Year | 01 | Month | 08 | Day |
Unpublished
30
Delay expected |
Under reviewer
Completed
2016 | Year | 03 | Month | 01 | Day |
2016 | Year | 02 | Month | 16 | Day |
2016 | Year | 03 | Month | 01 | Day |
2019 | Year | 01 | Month | 10 | Day |
2019 | Year | 02 | Month | 01 | Day |
2019 | Year | 02 | Month | 01 | Day |
2019 | Year | 11 | Month | 15 | Day |
2020 | Year | 01 | Month | 08 | Day |
2020 | Year | 01 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044560
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