UMIN-CTR Clinical Trial

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