UMIN-CTR Clinical Trial

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
Email	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
Email	hkishii@med.nagoya-u.ac.jp

Sponsor
Institute	Division of Cardiology, Nagoya Graduate School of Medicine
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031182