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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007106
Receipt No. 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

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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
Last 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
1st 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
Institute Kanagawa PTCA Conference
Institute
Department

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
URL(English) https://upload.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


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