UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025749 |
|---|---|
| Receipt number | R000029623 |
| Scientific Title | Effect of Canagliflozin on sympathetic activity and coronary plaque in DM patients with ACS |
| Date of disclosure of the study information | 2017/01/23 |
| Last modified on | 2019/03/22 10:53:13 |
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Basic information
Public title
Effect of Canagliflozin on sympathetic activity and coronary plaque in DM patients with ACS
Acronym
Effect of Canagliflozin on sympathetic activity and coronary plaque in DM patients with ACS
Scientific Title
Effect of Canagliflozin on sympathetic activity and coronary plaque in DM patients with ACS
Scientific Title:Acronym
Effect of Canagliflozin on sympathetic activity and coronary plaque in DM patients with ACS
Region
| Japan |
Condition
Condition
DM Patients with ACS
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Elucidation of the mechanism of inhibitory effect of SGLT2 inhibitor on cardiovascular events in DM patients with ACS
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
NTproBNP
Sympathetic activity
Key secondary outcomes
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
Canagliflozin 100mg/day, 36 weeks
Interventions/Control_2
standard therapy, 36 weeks
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. >=20 years old
2.Type 2 DM(>=HbA1c6.5%) with ACS
3.PCI would be required
4.Patients giving written concent by their own volition after being provided sufficient explanation for participation in this clinical trial
Key exclusion criteria
1. Patients receiving insulin injection for DM treatment
2.Severe heart failure
3.Advenced CKD(<eGFR30ml/min or HD)
4.Contraindication of Canagliflozin
5.patinets who are ineligible in the opinion of the investigator
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | TadateruTakayama |
Organization
Nihon University Itabashi Hospital
Division name
Department of Cardiology
Zip code
Address
30-1 Oyaguchi kamichou, Itabashi-ku, Tokyo, Japan 173-8610
TEL
03-3972-8111
Hirayama.atsushi@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadateru Takayama |
Organization
Nihon University Itabashi Hospital
Division name
Department of Cardiology
Zip code
Address
30-1 Oyaguchi kamichou, Itabashi-ku, Tokyo, Japan 173-8610
TEL
03-3972-8111
Homepage URL
takayama.tadateru@nihon-u.ac.jp
Sponsor or person
Institute
Dividion of Cardiology, Department of Medicine, Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Mitsubishi Tanabe pharma corporation
Organization
Division
Category of Funding Organization
Profit organization
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
| 2017 | Year | 01 | Month | 23 | 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
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 02 | Month | 27 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 20 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 19 | Day |
Last modified on
| 2019 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029623
