UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039079
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

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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 or person

Institute

Department of Cardiology, NTT Medical Center Tokyo

Institute

Department

Personal name



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

Value
https://center6.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