UMIN-CTR Clinical Trial

Public title

Examination about the influence that DPP-4 inhibitor gives for a left ventricle function in acute myocardial infarction

Acronym

Examination about the influence that DPP-4 inhibitor gives for a left ventricle function in acute myocardial infarction

Scientific Title

Examination about the influence that DPP-4 inhibitor gives for a left ventricle function in acute myocardial infarction

Scientific Title:Acronym

Examination about the influence that DPP-4 inhibitor gives for a left ventricle function in acute myocardial infarction

Region

Japan

Condition

acute myocardial infarction, type2 diabetes mellitus

Classification by specialty

Cardiology

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

to examine the influence that the DPP-4 inhibitor gives the change of the left ventricle function by the comparison with the conventional treatment group

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Primary outcomes

the change of the left ventricle function in the echocardiography

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

In alogliptin group,patients will be administered alogliptin 6.25, 12.5, 25mg/day in nine-months after the percutaneous coronary intervention.

Interventions/Control_2

In conventional treatment group, patients wil be administrated oral hypoglycemic drug except DPP-4 inhibitor, GLP-1 preparation, insulin and pioglitazone.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) The patient that percutaneous coronary angioplasty was performed for acute myocardial infarction
2) The patient who is tested for diabetes (when during the hypoglycemic drug dosage more than 6% of HbA1c international standard levels in the case of less than 9%, the non-dosage more than 6% less than 10%)
3) The patient that a document agreement by the free will of a patient was provided after enough understanding after having received enough explanation on participating of the final examination
4) Age is a patient 80 years or younger 20 years old or older at the agreement acquisition

Key exclusion criteria

1) Severe renal disease or dialysis patient
2) Insulin-dependent patient (CPR index <0.8)
3) Patient of type I diabetes mellitus
4) The patient who uses DPP-4 inhibitor, GLP-1 preparation in either from three months ago before hospitalization to the hospitalization direct front
5) Patient having a serious liver disease
6) Patient with the possibility of the pregnancy or the pregnancy, the patient whom I am nursing
7) Patient having a side effect for DPP-4 inhibitor, antiplatelet and the anticoagulant
8) The patient who develops lower limbs confinement-related arteriosclerosis having severe lower limbs ischemia
9) Patient having heart failure of NYHAIV
10) In addition, the patient who judged an examination responsibility (allotment) doctor to be inappropriate as a subject

Target sample size

38

Name of lead principal investigator

1st name
Middle name
Last name	Yoshio Kobayashi

Organization

Chiba University Hospital

Division name

Center for Cardiovascular Interventions

Zip code

Address

1-8-1 Inohana,Chuo-ku,Chiba City

TEL

043-222-7171

Email

t-shoji@umin.ac.jp

Name of contact person

1st name
Middle name
Last name	Toshihiro Shoji

Organization

Chiba University Hospital

Division name

Center for Cardiovascular Interventions

Zip code

Address

1-8-1 Inohana,Chuo-ku,Chiba City

TEL

043-222-7171

Homepage URL

Email

t-shoji@umin.ac.jp

Institute

Center for Cardiovascular Interventions,Chiba University Hospital

Institute

Department

Personal name

Organization

Chugai Pharmaceutical Co

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2014

Year

07

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2014

Year

06

Month

13

Day

Date of IRB

Anticipated trial start date

2014

Year

06

Month

13

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

07

Month

11

Day

Last modified on

2014

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=R000016911