UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006890 |
|---|---|
| Receipt number | 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 10:17:28 |
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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
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
byi-senshin@jimu.kumamoto-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Faculty of Life Sciences, Kumamoto University Graduate School of Medical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008141
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
