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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039079
Receipt No. 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

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Basic information
Public title Effect of empagliflozin 12 months after drug eluting stent implantation in type 2 diabetics with stable angina.
Acronym Effect of empagliflozin after drug eluting stent implantation in type 2 diabetics.
Scientific Title Effect of empagliflozin 12 months after drug eluting stent implantation in type 2 diabetics with stable angina.
Scientific Title:Acronym Effect of empagliflozin after drug eluting stent implantation in type 2 diabetics.
Region
Japan

Condition
Condition Ischemic heart disease, Type 2 diabetes mellitus
Classification by specialty
Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Comparison of neointimal tissue 12 months after drug eluting stent between diabetes patients with empagliflozin treatment and standard therapy; evaluated by optical coherence tomography.
Key secondary outcomes 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).

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Additional treatment with empagliflozin in insuffiently controlled type 2 diabetes.
Interventions/Control_2 Intensive additional standard treatment without SGLT-2 inhibitor in insuffiently controlled type 2 diabetes.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria 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.
Key exclusion criteria 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
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Masao
Middle name
Last name Yamasaki
Organization NTT Medical center Tokyo
Division name Department of Cardiology
Zip code 141-0022
Address 5-9-22 Higashigotanda, Shinagawa, Tokyo
TEL +81-3-3448-6111
Email masayamlmt99@gmail.com

Public contact
Name of contact person
1st name Takehiro
Middle name
Last name Hashikata
Organization NTT Medical Center Tokyo
Division name Department of Cardiology
Zip code 141-0022
Address 5-9-22 Higashigotanda, Shinagawa, Tokyo
TEL +81-3-3448-6111
Homepage URL
Email t_hashikata@med.kitasato-u.ac.jp

Sponsor
Institute Department of Cardiology, NTT Medical Center Tokyo
Institute
Department

Funding Source
Organization Department of Cardiology, NTT Medical Center Tokyo
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization NTT Medical Center Tokyo
Address 5-9-22 Higashigotanda, Shinagawa, Tokyo
Tel +81-3-3448-6111
Email mutsumi.fujimoto@east.ntt.co.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions NTT東日本関東病院

Other administrative information
Date of disclosure of the study information
2020 Year 01 Month 08 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 30
Results
Results date posted
Results Delayed
Delay expected
Results Delay Reason Under reviewer
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 03 Month 01 Day
Date of IRB
2016 Year 02 Month 16 Day
Anticipated trial start date
2016 Year 03 Month 01 Day
Last follow-up date
2019 Year 01 Month 10 Day
Date of closure to data entry
2019 Year 02 Month 01 Day
Date trial data considered complete
2019 Year 02 Month 01 Day
Date analysis concluded
2019 Year 11 Month 15 Day

Other
Other related information

Management information
Registered date
2020 Year 01 Month 08 Day
Last modified on
2020 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044560

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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