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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000006890
Receipt No. R000008141
Scientific Title Effect of Nicorandil on Coronary Microvascular Dysfunction in Diabetic Patients With Coronary Artery Disease
Date of disclosure of the study information 2011/12/16
Last modified on 2017/06/18

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Basic information
Public title Effect of Nicorandil on Coronary Microvascular Dysfunction in Diabetic Patients With Coronary Artery Disease
Acronym COMBO Study
Scientific Title Effect of Nicorandil on Coronary Microvascular Dysfunction in Diabetic Patients With Coronary Artery Disease
Scientific Title:Acronym 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
1st name
Middle name
Last name Hisao Ogawa
Organization Faculty of Life Sciences, Kumamoto University Graduate School of Medical Sciences
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1-1 Honjo, Kumamoto City
TEL 096-373-5175
Email ogawah@kumamoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name N/A
Organization Kumamoto University Hospital
Division name Institutional Review Board
Zip code
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)

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
2011 Year 12 Month 16 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 12 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000008141

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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