UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017861 |
|---|---|
| Receipt number | R000020695 |
| Scientific Title | assessment in patients with Type 2 diabetes mellitus in addition to cOronary artery disease after Percutaneous coronary intervention with regard to Sitagliptin-induced COronary plaque REgression (TOP-SCORE) |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2017/06/22 19:41:29 |
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Basic information
Public title
assessment in patients with Type 2 diabetes mellitus in addition to cOronary artery disease after Percutaneous coronary intervention with regard to Sitagliptin-induced COronary plaque REgression (TOP-SCORE)
Acronym
TOP-SCORE study
Scientific Title
assessment in patients with Type 2 diabetes mellitus in addition to cOronary artery disease after Percutaneous coronary intervention with regard to Sitagliptin-induced COronary plaque REgression (TOP-SCORE)
Scientific Title:Acronym
TOP-SCORE study
Region
| Japan |
Condition
Condition
Coronary artery disease with type 2 diabetes mellitus (T2DM)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the effect of Sitagliptin on coronary plaque regression using intravasucular ultrasound (IVUS) in patients with T2DM who received percutaneous coronary intervention (PCI) and to investigate various indicators of progression or regression of coronary plaque.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Nominal change in percent atheroma volume (PAV) from baseline to 8-12 month`s follow-up determined by IVUS after Sitagliptin treatment IVUS
Key secondary outcomes
(1) Percent change in total atheroma volume (TAV) determined by IVUS
(2) Change in levels of low-density lipoprotein cholesterol, triglyceride, high-density lipoprotein cholesterol, hemoglobin A1c, blood sugar and blood pressure
(3) Association between lipid profile and the change in PAV
(4) Association between biomarker and the change in PAV
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Interventions (sitagliptin group)
The period of intervention: 8-12 months
The dosage of Sitagliptin: 50-100mg/day
Interventions/Control_2
Control (non-sitagliptin group)
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) T2DM patients 30 years of age or older who needed percutaneous coronary intervention (PCI)
(2) T2DM patients with a baseline hemoglobin A1c (National Glycohemoglobin Standardization Program) level of 6.2% to 9.9% (if taking any hypoglycemic agents) or 6.5% to 9.9% (if receiving no medical treatment)
(3) Patients treated dyslipidemia according to Japan Atherosclerosis Society Guideline for the Diagnosis and Prevention of Atherosclerotic Cardiovascular Diseases 2007 or 2012 version
(4) written consent for participation in the study
Key exclusion criteria
(1) type 1 diabetes mellitus
(2) patients who had experienced ketosis, diabetic coma and/or pre-coma within six months prior to providing consent
(3) moderate to severe heart failure (New York Heart Association class 3 or 4, left ventricular ejection fraction <40%)
(4) severe valvular heart disease
(5) renal dysfunction (creatinine blood level of over 1.5 mg/dL in men and over 1.3 mg/dL in women)
(6) familial hypercholesterolemia
(7) contraindication to antiplatelet agent(8) history of chemical sensitivity to DPP4-I
(9) pregnancy or lactation
(10) severe infection, trauma or recent surgery
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keijiro Saku |
Organization
Fukuoka University School of Medicine
Division name
Department of Cardiology
Zip code
Address
7-45-1 Nanakuma, Jonan-Ku, Fukuoka.
TEL
81-92-801-1011
saku-k@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Iwata |
Organization
Fukuoka University School of Medicine
Division name
Department of Cardiology
Zip code
Address
7-45-1 Nanakuma, Jonan-Ku, Fukuoka.
TEL
81-92-801-1011
Homepage URL
iwaiwa@fukuoka-u.ac.jp
Sponsor or person
Institute
Department of Cardiology, Fukuoka University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The principal investigator had a grant from the Public Interest Incorporated Foundation and an Endowed Department supported by MSD Co., Ltd. and Izumi City, Kagoshima, Japan.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The addition of sitagliptin to statins did not cause coronary plaque regression in Type 2 diabetes mellitus with coronary artery disease.
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
| 2011 | Year | 04 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 15 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 04 | Month | 11 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 10 | Day |
Last modified on
| 2017 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020695
