UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Nicorandil on Coronary Microvascular Dysfunction in Diabetic Patients With Coronary Artery Disease
Title of the study (Brief title)	COMBO Study
Region	Japan

Condition
Condition	Diabetic Patients With Coronary Aretry Disease
Classification by specialty	Medicine in general Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effect of Nicorandil on coronary microvascular dysfunction in diabetic patients with coronary artery disease using new parameter of microcirculatory dysfunction (hyperemic microvascular resistance: h-MRv).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Parameter of microcirculatory dysfunction (hyperemic microvascular resistance: h-MRv) at index procedure and follow angiography
Key secondary outcomes	-Quantitative and qualitative analysis of carotid artery plaque using ultrasonography -Endo-PAT2000(Parameter of Endothelial Dysfunction) -ABI -UCG Findings (EF, LVDd, IVS/PW, LAD, E/e') -Lipid Profile (LDL-C, HDL-C, TG, FFA, RLP-C, Apo-AI, Apo-AII, ApoB, Apo-CII, Apo-CIII) -Abdominal US (fatty liver) -Abdominal Circumference -Inflammation Marker (hs-CRP) -Diabetic Status (IRI, FBS, adiponectin, 75g OGTT, HbA1c) -Labolatory Data (AST, ALT, LDH, CPK, Scr, e-GFR) -Adverse Events (Cardiac Death, Nonfatal MI, Unatable Angina, Revascularization, heart failure, stroke, New Coronary Lesion)

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	Nicorandil Group
Interventions/Control_2	Non-Nicorandil 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	85 years-old >
Gender	Male and Female
Key inclusion criteria	Consecutive Diabetic Patients Undergoing Percutaneous Coronary Intervention to Non-LAD Lesions Who Deos Not Have Contraindication of Nicorandil
Key exclusion criteria	-Renal Dysfunction (Scr>=2.0) -Liver Dysfunction (AST, ALT>=3ULN -Hemodialysis Patients (HD, PD) -Allergic to Study Drug (Nicorandil) -Severe Illness -Lack Decision-Making Capacity
Target sample size	40

Research contact person
Name of lead principal investigator	Hisao Ogawa
Organization	Faculty of Life Sciences, Kumamoto University Graduate School of Medical Sciences
Division name	Department of Cardiovascular Medicine
Address	1-1-1 Honjo, Kumamoto City
TEL	096-373-5175
Email	ogawah@kumamoto-u.ac.jp

Public contact
Name of contact person	N/A
Organization	Kumamoto University Hospital
Division name	Institutional Review Board
Address	1-1-1 Honjo, Chuo-ku, Kumamoto
TEL	096-373-5965
Homepage URL
Email	byi-senshin@jimu.kumamoto-u.ac.jp

Sponsor
Institute	Department of Cardiovascular Medicine, Faculty of Life Sciences, Kumamoto University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
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	2011 Year 12 Month 16 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 12 Month 01 Day
Anticipated trial start date	2011 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 12 Month 15 Day
Last modified on	2017 Year 06 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008141