UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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)
Title of the study (Brief title)	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	Keijiro Saku
Organization	Fukuoka University School of Medicine
Division name	Department of Cardiology
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	Atsushi Iwata
Organization	Fukuoka University School of Medicine
Division name	Department of Cardiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 04 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	The addition of sitagliptin to statins did not cause coronary plaque regression in Type 2 diabetes mellitus with coronary artery disease.
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