UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023103
Receipt number R000025961
Scientific Title Clinical response of recurrence risk and the SGLT2 inhibitor of the ischemic heart disease
Date of disclosure of the study information 2016/07/11
Last modified on 2016/07/11 10:18:21

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Basic information

Public title

Clinical response of recurrence risk and the SGLT2 inhibitor of the ischemic heart disease

Acronym

Clinical response of recurrence risk and the SGLT2 inhibitor of the ischemic heart disease

Scientific Title

Clinical response of recurrence risk and the SGLT2 inhibitor of the ischemic heart disease

Scientific Title:Acronym

Clinical response of recurrence risk and the SGLT2 inhibitor of the ischemic heart disease

Region

Japan


Condition

Condition

the patients of ischemic heart disease and type2 DM who performed elective percutaneous coronary intervention

Classification by specialty

Cardiology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Clinical response of recurrence risk and the SGLT2 inhibitor of the ischemic heart disease

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

death,or hospitalization due to heart failure and unstable angina

Key secondary outcomes

chest X-ray, body weight, blood pressure, haert rate, renal function, liver function, serum lipid, UCG, optical coherence tomografy


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

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

The SGLT2 inhibitor limits it to empagliflozin 10mg or 25mg.

Interventions/Control_2

We do not give the SGLT2 inhibitor in the control group.

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

20 years-old <=

Age-upper limit

85 years-old >

Gender

Male and Female

Key inclusion criteria

The patients with ischemic heart disease and type2 DM who will be performed elective PCI.

Key exclusion criteria

(1)hemodyaliysis
(2)eGFR<30ml/min/1.73m2
(3)possibility of the dehydration

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Eiji Ojima

Organization

Mito Kyodo General Hospital , Tsukuba University Hospital Mito Clinical Education and Training Center

Division name

Department of cardiology

Zip code


Address

3-2-7, Miya-machi, Mito city, Ibaraki, JAPAN

TEL

+81-29-231-2371

Email

ojima-tuk@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Eiji Ojima

Organization

Mito Kyodo General Hospital , Tsukuba University Hospital Mito Clinical Education and Training Cente

Division name

Department of cardiology

Zip code


Address

3-2-7, Miya-machi, Mito city, Ibaraki, JAPAN

TEL

+81-29-231-2371

Homepage URL


Email

ojima-tuk@umin.ac.jp


Sponsor or person

Institute

Mito Kyodo General Hospital , Tsukuba University Hospital Mito Clinical Education and Training Center

Institute

Department

Personal name



Funding Source

Organization

Mito Kyodo General Hospital , Tsukuba University Hospital Mito Clinical Education and Training Center

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

総合病院水戸協同病院・筑波大学附属病院水戸地域医療教育センター(茨城県)


Other administrative information

Date of disclosure of the study information

2016 Year 07 Month 11 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


Results


Results date posted


Results Delayed


Results Delay Reason


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

Date of protocol fixation

2016 Year 07 Month 11 Day

Date of IRB


Anticipated trial start date

2016 Year 07 Month 11 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 07 Month 11 Day

Last modified on

2016 Year 07 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025961


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name