UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027422 |
|---|---|
| Receipt number | R000031182 |
| Scientific Title | Effects of Dapagliflozin on Stabilizing Coronary Atherosclerotic Plaques: Using IB-IVUS Imaging Study |
| Date of disclosure of the study information | 2017/09/01 |
| Last modified on | 2020/12/23 21:43:11 |
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Basic information
Public title
Effects of Dapagliflozin on Stabilizing Coronary Atherosclerotic Plaques: Using IB-IVUS Imaging Study
Acronym
Effects of Dapagliflozin on Stabilizing Coronary Atherosclerotic Plaques: Using IB-IVUS Imaging Study
Scientific Title
Effects of Dapagliflozin on Stabilizing Coronary Atherosclerotic Plaques: Using IB-IVUS Imaging Study
Scientific Title:Acronym
Effects of Dapagliflozin on Stabilizing Coronary Atherosclerotic Plaques: Using IB-IVUS Imaging Study
Region
| Japan |
Condition
Condition
ischemic heart disease
diabets
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To detect the efficacy of dapagliflozin, a SGLT2 inhibitor, for reducing and stabilizing coronary plaque in patients with both diabetes and ischemic heart disease, undergoing conventional- and IB-IVUS.
2. To detect the effects of dapagliflozin on left ventricular function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Region of interest will be measured by volumetric IVUS at both baseline and 1-year follow-up period.
(i) Conventional IVUS: Changes of the percent plaque volume assessed by IVUS.
(ii) IB IVUS analysis: Changes of the percent of coronary lipid and fibrous volume assessed by IB-IVUS.
The final IVUS exam of PCI is used for IVUS analysis. The target segment is determined in a non-PCI site (> 5 mm proximal or distal to the PCI site), with < 50 % stenosis of the lumen diameter on coronary angiography, in addition to the percentage of plaque area > 20 % at the lumen cross-sectional area. The target segments are assessed at an axial interval of 1 mm for each plaque.
Key secondary outcomes
1. Ultrasound of cardiography
2. Major adverse cardio-cerebrovascular events
3. Carotid intima-medial thickness
4. BNP
5. HbA1c and FPG
6. Lipid profile
7. General urinary test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
Patients are divided into two groups; Intervention group or control group. Treatment period is 12 months.
Intervention group: T2DM patients with treatment with dapagliflozin 5mg/day in addition to conventional therapy or those with only conventional therapy for 12 months, starting immediately after PCI. On or after week 12, if HbA1c were >7.5% and there were no safety concerns, dapagliflozin would be up-titrated to 10 mg/day. If HbA1c remains above 7.5% during follow period at week 24 and/or at week 36 from week 24 to week 48, only one additional OAD could be added and gradually increased up to the approved maximum dose at discretion of investigators. Pioglitazone cannot be used as an additional OAD.
Randomization is performed using the RANDBETWEEN function of Excel (Microsoft Corporation, Redmond, United States of America).
Interventions/Control_2
Control group: Conventional treatment
On or after week 12, if HbA1c were >7.5% and there were no safety concerns, doses of the basal OAD will be gradually increased up to the approved maximum doses and then, if HbA1c remains above 7.5% during follow period at week 24 and/or at week 36 necessary, only one additional OAD will be added and gradually increased up to the approved maximum dose at the discretion of investigators following local regulation and treatment guidelines in Japan. Pioglitazone cannot be used as an additional OAD.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. T2DM patients who need PCI due to ischemic heart disease.
2. Patients with baseline HbA1c levels >=6.5% and <9%.
3. Patients are currently treated with one or multiple OADs other than pioglitazone or drug naive patients.
4. Patients who have already received treatment with statin.
5. Patients receiving written informed consent.
Key exclusion criteria
1)Patients with severe ketosis, diabetic coma or precoma
2)Patients with severe infection, perioperative, a severe trauma
3)Patients with moderate renal dysfunction (eGFR: less than 45 ml/min/1.73m2)
4)Patients with severe hepatic dysfunction
5)Patients who are treated with insulin
6)Patients who need treatment with pioglitazone
7)Patients who need treatment with GLP-1RA
8)Patients with a history of hypersensitivity to SGLT-2 inhibitors
9)Women who are or may be pregnant
10)Patients who are treated with PCSK-9 inhibitor
11)Patients who have been determined to be unsuitable for the attending physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toyoaki Murohara |
Organization
Nagoya Graduate School of Medicine
Division name
Cardiology
Zip code
Address
65-Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2150
murohara@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Ishii |
Organization
Nagoya Graduate School of Medicine
Division name
Cardiology
Zip code
Address
65-Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2150
Homepage URL
hkishii@med.nagoya-u.ac.jp
Sponsor or person
Institute
Division of Cardiology, Nagoya Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca plc
Ono pharmacy
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 | 09 | Month | 01 | 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
| 2017 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 21 | Day |
Last modified on
| 2020 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031182
