UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011263
Receipt number R000011082
Scientific Title Impact of Sitagliptin on the Progression of Coronary Atherosclerosis in Diabetes Patients with Angina Pectoris
Date of disclosure of the study information 2013/08/01
Last modified on 2019/01/28 05:55:25

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Basic information

Public title

Impact of Sitagliptin on the Progression of Coronary Atherosclerosis in Diabetes Patients with Angina Pectoris

Acronym

Sitagliptin and coronary atherosclerosis

Scientific Title

Impact of Sitagliptin on the Progression of Coronary Atherosclerosis in Diabetes Patients with Angina Pectoris

Scientific Title:Acronym

Sitagliptin and coronary atherosclerosis

Region

Japan


Condition

Condition

Diabetic patients with angina pectoris scheduled underwent percutaneous coronary intervention with drug eluting stent.

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to investigate the effect of sitagliptin on coronary atherosclerosis.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes in plaque volume of coronary atherosclerosis assessed by intravascular ultrasound and plaque characteristics assessed by optical coherence tomography

Key secondary outcomes



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

Sitagliptin treatment group;
Clinical investigators will initiate sitagliptin treatment after PCI

Interventions/Control_2

Sitaglitptin non-treatment group;
Clinical investigators will treat with oral antidiabetic agents except for sitagliptin

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

1)Type2 diabetes
2)Stable angina pectoris with scheduled PCI
3)PCI with drug-eluting stent
4)informed consent for participation in the study

Key exclusion criteria

1)Acute myocardial infarction and cardiogenic shock
2)PCI for left main trunk
3)Type1 diabetes
4)Severe ketosis and coma with in 6 months
5)Severe renal deficiency 6)Hemodyalysis
7)Treatment with immunosuppresant
8)Treatment with pioglitazone, glynide and insulin
9)Treatment with DPP4 except for sitagliptin
10)Hypersensitivity to sitagliptin
11)Pregnant and possible pregnat women
12)Malignancy
13)Judged as ineligible by clinical investigators

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Minoru Yoshiyama

Organization

Osaka City University Graguate School of Medicine

Division name

Cardiovascular Medcine

Zip code


Address

1-4-3 Asahi-machi, Abeno-ku, Osaka City

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Osaka City University Graguate School of Medicine

Division name

Cardiovascular Medcine

Zip code


Address

1-4-3 Asahi-machi, Abeno-ku, Osaka City

TEL


Homepage URL


Email



Sponsor or person

Institute

Osaka City University

Institute

Department

Personal name



Funding Source

Organization

Osaka City University

Organization

Division

Category of Funding Organization

Non profit foundation

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



Other administrative information

Date of disclosure of the study information

2013 Year 08 Month 01 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

Enrolling by invitation

Date of protocol fixation

2012 Year 07 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 05 Month 01 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

2013 Year 07 Month 24 Day

Last modified on

2019 Year 01 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011082


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name