UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007106
Receipt number R000008371
Scientific Title Trial of Atheroma Regression Evaluated with Integrated Backscatter Intravascular Ultrasound by administering Sitagliptin
Date of disclosure of the study information 2012/02/01
Last modified on 2015/07/25 12:35:02

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Basic information

Public title

Trial of Atheroma Regression Evaluated with Integrated Backscatter Intravascular Ultrasound by administering Sitagliptin

Acronym

TRUST Study

Scientific Title

Trial of Atheroma Regression Evaluated with Integrated Backscatter Intravascular Ultrasound by administering Sitagliptin

Scientific Title:Acronym

TRUST Study

Region

Japan


Condition

Condition

Stable coronary artery disease patients with type 2 diabetes

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparison of effect of DPP-4 inhibitor and non-DPP-4 inhibitor on coronary atherosclerosis and plaque composition

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change in plaque volume using Intravascular Ultrasound (IVUS)

Key secondary outcomes

Change in plaque composition using Integrated Backscatter Intravascular Ultrasound (IB-IVUS), and change in lipids and glucose markers, and hs-CRP


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Sitagliptn

Interventions/Control_2

Sulfonylurea

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Patients with type 2 diabetes
2)6.1%<=HbA1c <9.0% (JDS) or 6.5%<=HbA1c <9.4% (NGSP)
3)Stable coronary artery disease

Key exclusion criteria

1)Patients with type 1diabetes
2)Patients with ACS
3)patients with contraindication of antiplatelet drug
4)Patients with severe ketosis, diabetic coma or precoma within 6 months
5)Patients with severe infections, before or after operation, or serious trauma .
6)Patients with moderate renal dysfunction (sCr: male>1.5mg/dl, female>1.3mg/dl)
7)Patients who are pregnant, breast-feeding and/or intention to become pregnant
8)Patients with allergy against sitagliptin
9)Other patients determined to be inappropriate by physician

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ichiro Michishita

Organization

Yokohama Sakae Kyosai Hospital

Division name

Division of Cardiology, Department of Internal Medicine

Zip code


Address

132 Katsura-cho, Sakae-ku, Yokohama

TEL

045-891-2171

Email

i-michishita@yokohamasakae.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tsuyoshi Nozue

Organization

Yokohama Sakae Kyosai Hospital

Division name

Division of Cardiology, Department of Internal Medicine

Zip code


Address

132 Katsura-cho, Sakae-ku, Yokohama

TEL

045-891-2171

Homepage URL


Email

nozue2493@yahoo.co.jp


Sponsor or person

Institute

Kanagawa PTCA Conference

Institute

Department

Personal name



Funding Source

Organization

Japan Heart Foundation

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

2012 Year 02 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

Completed

Date of protocol fixation

2012 Year 01 Month 19 Day

Date of IRB


Anticipated trial start date

2012 Year 02 Month 01 Day

Last follow-up date

2015 Year 01 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 01 Month 20 Day

Last modified on

2015 Year 07 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008371


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name