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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007255
Receipt No. R000008557
Scientific Title Effect of DPP-4(dipeptidyl peptidase-4) inhibitor for coronary plaque in diabetes patients.
Date of disclosure of the study information 2012/02/09
Last modified on 2014/09/09

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Basic information
Public title Effect of DPP-4(dipeptidyl peptidase-4) inhibitor for coronary plaque in diabetes patients.
Acronym Effect of DPP-4 inhibitor for coronary plaque in diabetes patients.
Scientific Title Effect of DPP-4(dipeptidyl peptidase-4) inhibitor for coronary plaque in diabetes patients.
Scientific Title:Acronym Effect of DPP-4 inhibitor for coronary plaque in diabetes patients.
Region
Japan

Condition
Condition Ischemic Heart Disease,Diabetes Mellitus
Classification by specialty
Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the effect of glimepiride or vildagliptin for coronary plaque in one-year after the percutaneous coronary intervention in diabetes patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in coronary plaque volume
Key secondary outcomes 1)Change in coronary plaque character by IB-IVUS (integrated backscatter intravascular ultrasound).
2)HbA1c,BS,TG,LDL-CHO,HDL-CHO.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 In vildagliptin group,patients will be administered vildagliptin 100mg/day in one-year after the percutaneous coronary intervention.
Interventions/Control_2 In glimepiride group,patients will be administered glimepiride 1-4mg/day in one-year after the percutaneous coronary intervention.
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 who underwent stent implantation for coronary heart disease.
2) Type2 diabetes mellitus with HbA1c level of 6.0% to 9.0% (if taking a glucose-lowering medication) or 6.5% to 10% (if not currently receiving drug therapy).
Key exclusion criteria 1)Patients with severe coronary stenosis who are eligible for IVUS.
2)Acute myocardial infarction
3)Patients who have unprotected LMT lesion.
4)Severe renal disease or/and serum creatinine level>2.0mg/dl
5)Left ventricular ejection fraction=<40%
6)Type1 diabetes mellitus
7)Allergy for antiplatelet,anticoagulant drug,dipeptidyl-peptidase4 inhibitor and sulfonylureas
8)Severe liver dysfunction
9)Pregnancy
10)Other patients judged as being inappropriate for the subjects of the study by investigators.
Target sample size 128

Research contact person
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 yoshio.kobayashi@wonder.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keiichiro Miura
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 markone@hospital.chiba-u.jp

Sponsor
Institute Center for Cardiovascular Interventions,Chiba University Hospital
Institute
Department

Funding Source
Organization Center for Cardiovascular Interventions,Chiba University Hospital
Organization
Division
Category of Funding Organization Self funding
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 09 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 Terminated
Date of protocol fixation
2011 Year 10 Month 26 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 26 Day
Last follow-up date
Date of closure to data entry
2014 Year 06 Month 30 Day
Date trial data considered complete
2014 Year 06 Month 30 Day
Date analysis concluded
2014 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2012 Year 02 Month 09 Day
Last modified on
2014 Year 09 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008557

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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