UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037291 |
|---|---|
| Receipt number | R000042438 |
| Scientific Title | Exploring Mechanistic Study: Potential of Luseogliflozin on Restoration of Cardiomyocyte Energy Metabolism in Diabetic Patients with Coronary Artery Disease |
| Date of disclosure of the study information | 2019/07/05 |
| Last modified on | 2021/08/02 18:07:14 |
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Basic information
Public title
Exploring Mechanistic Study: Potential of Luseogliflozin on Restoration of Cardiomyocyte Energy Metabolism in Diabetic Patients with Coronary Artery Disease
Acronym
EXPLORE-CAD
Scientific Title
Exploring Mechanistic Study: Potential of Luseogliflozin on Restoration of Cardiomyocyte Energy Metabolism in Diabetic Patients with Coronary Artery Disease
Scientific Title:Acronym
EXPLORE-CAD
Region
| Japan |
Condition
Condition
Type 2 Diabetes
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To elucidate changes of cardiac metabolism by SGLT2 inhibitor usage
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes of blood metabolic profiles
Key secondary outcomes
Change of diastolic dysfunction
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
Luseogliflozin
Interventions/Control_2
Standard Therapy without Luseogliflozin
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetes patients who are planed percutaneous coronary intervention for the treatment of angina pectoris.
Key exclusion criteria
1. Type 1 diabetes
2. Unstable angina
3. 3-vessel disease
4. insulin usage
5. eGFR < 45ml/min/1.73m2
6. Liver failure (Child-Pugh: Type C)
7. Severe Heart failure (NYHA Stage4)
8. BMI <18.5kg/m2
9. Allergic reaction to drugs
10. Pregnant, breastfeeding patients or suspected patients
11. Patients with malignant diseases
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Tsujita |
Organization
Kumamoto University
Division name
Cardiovascular Medicine
Zip code
860-8556
Address
1-1-1 Honjo, Kumamoto City, Kumamoto, JAPAN
TEL
096-373-5175
cvmhisho@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuichiro |
| Middle name | |
| Last name | Arima |
Organization
Kumamoto University
Division name
Cardiovascular Medicine
Zip code
860-8556
Address
1-1-1 Honjo, Kumamoto City, Kumamoto, JAPAN, 860-8556
TEL
096-373-5175
Homepage URL
arimay@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Commity, Kumamoto University
Address
1-1-1 Honjo, Kumamoto City, Kumamoto, Japan
Tel
096-373-5657
ski-shien@jimu.kumamoto-u.ac.jp
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
| 2019 | Year | 07 | Month | 05 | Day |
Related information
URL releasing protocol
Unpublished
Publication of results
Unpublished
Result
URL related to results and publications
Unpublished
Number of participants that the trial has enrolled
0
Results
Case registration did not proceed, and it was judged that it would be difficult to carry out the research using the protocol at the time of application.
Results date posted
| 2021 | Year | 08 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Type 2 diabetes with ischemic heart disease.
Participant flow
Metabolic variability in the heart will be assessed by two catheterizations at study enrollment and 9 months later.
Adverse events
None
Outcome measures
None
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2018 | Year | 09 | Month | 16 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 05 | Day |
Last modified on
| 2021 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042438
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
