Unique ID issued by UMIN | UMIN000015316 |
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Receipt number | R000017459 |
Scientific Title | Effect of EPA/DHA treatment on coronary hyperintense plaque detected by non-contrast T1-weighted magnetic resonance imaging |
Date of disclosure of the study information | 2014/10/10 |
Last modified on | 2014/12/18 10:02:20 |
Effect of EPA/DHA treatment on coronary hyperintense plaque detected by non-contrast T1-weighted magnetic resonance imaging
Effect of EPA/DHA treatment on coronary hyperintense plaque detected by magnetic resonance imaging
Effect of EPA/DHA treatment on coronary hyperintense plaque detected by non-contrast T1-weighted magnetic resonance imaging
Effect of EPA/DHA treatment on coronary hyperintense plaque detected by magnetic resonance imaging
Japan |
coronary artery disease with dyslipidemia
Cardiology |
Others
NO
The objective of the present study is to evaluate, in an exploratory manner, the effect of omega-3-acid ethyl esters on coronary plaque in hyperlipidemic patients with coronary artery disease by cardiac magnetic resonance (CMR) imaging using non-treatment group as the control group.
Efficacy
Exploratory
Change in plaque to myocardium ratio (PMR) in the primary lesion measured by non-contrast T1-weighted cardiac magnetic resonance (CMR) imaging (change at study completion or discontinuation from baseline)
1) Change in plaque to myocardium ratio (PMR) in all lesions measured by non-contrast T1-weighted cardiac magnetic resonance (CMR) imaging (change at study completion or discontinuation from baseline)
2) Percent change in plaque to myocardium ratio (PMR) in the primary lesion measured by non-contrast T1-weighted cardiac magnetic resonance (CMR) imaging (percent change at study completion or discontinuation from baseline)
3) Percent change in plaque to myocardium ratio (PMR) in all lesions measured by non-contrast T1-weighted cardiac magnetic resonance (CMR) imaging (percent change at study completion or discontinuation from baseline)
4) Changes in Hounsfield units, plaque volume, vessel area, and plaque area in the primary lesion measured by computed tomography angiography (CTA) (change at study completion or discontinuation from baseline)
5) Changes in Hounsfield units, plaque volume, vessel area, and plaque area in all lesions measured by computed tomography angiography (CTA) (change at study completion or discontinuation from baseline)
6) Percent changes in Hounsfield units, plaque volume, vessel area, and plaque area in the primary lesion measured by computed tomography angiography (CTA) (percent change at study completion or discontinuation from baseline)
7) Percent changes in Hounsfield units, plaque volume, vessel area, and plaque area in all lesions measured by computed tomography angiography (CTA) (percent change at study completion or discontinuation from baseline)
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
YES
Central registration
3
Treatment
Medicine |
2-g group: Subjects will take 2 g per dose of omega-3-acid ethyl esters once daily, immediately after meal.
4-g group: Subjects will take 2 g per dose of omega-3-acid ethyl esters twice daily, immediately after meal.
No-treatment group: Subjects will not take omega-3-acid ethyl esters.
20 | years-old | <= |
Not applicable |
Male and Female
1. Diagnosed with hyperlipidemia and receiving instructions for lifestyle modification
2. Diagnosed with coronary artery disease and have coronary stenosis exceeding 25%, as measured by computed tomography angiography (CTA)
3. Have been taking an HMG-CoA reductase inhibitor at a fixed dose and administration method from at least 4 weeks before informed consent
4. Have at least one coronary plaque with a plaque to myocardium ratio (PMR) of 1.0 or more in non-contrast T1-weighted cardiac magnetic resonance (CMR) imaging at the screening test
5. Serum LDL-cholesterol level less than 80 mg/dL at the screening test
6. Age more than 20 years at the time of consent
7. Capable of visiting the study centers on an outpatient basis
8. Capable of providing written consent before participation in this study
1. Use of EPA preparation within 12 weeks before informed consent
2. Scheduled to undergo percutaneous coronary intervention (PCI) or coronary-artery bypass grafting (CABG) during the observation period
3. Presence of type 1 diabetes mellitus or type 2 diabetes mellitus with uncontrolled hyperglycemia (HbA1C more than;8.0%)
4. Presence of bleeding (e.g., hemophilia, capillary fragility, gastrointestinal tract ulcer, urinary tract bleeding, hemoptysis, vitreous hemorrhage)
5. History of hypersensitivity to any component of the investigational product
6. Other patients who are inappropriate for participation in this study in the opinion of the principal investigator or investigator.
150
1st name | |
Middle name | |
Last name | Satoshi Yasuda |
National Cerebral and Cardiovascular Center
Department of Cardiovascular Medicine
5-7-1 Fujishirodai, Suita, Osaka Japan
06-6833-5012
yasuda.satoshi.hp@ncvc.go.jp
1st name | |
Middle name | |
Last name | Teruo Noguchi |
National Cerebral and Cardiovascular Center
Department of Cardiovascular Medicine
5-7-1 Fujishirodai, Suita, Osaka Japan
06-6833-5012
tnoguchi@hsp.ncvc.go.jp
Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center
Takeda Pharmaceutical Co., Ltd.
Profit organization
NO
2014 | Year | 10 | Month | 10 | Day |
Unpublished
Enrolling by invitation
2014 | Year | 05 | Month | 31 | Day |
2014 | Year | 12 | Month | 20 | Day |
2014 | Year | 10 | Month | 02 | Day |
2014 | Year | 12 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017459
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