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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017861
Receipt No. 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

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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
Email 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
Email iwaiwa@fukuoka-u.ac.jp

Sponsor
Institute Department of Cardiology, Fukuoka University School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020695

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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