UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015316
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

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Basic information

Public title

Effect of EPA/DHA treatment on coronary hyperintense plaque detected by non-contrast T1-weighted magnetic resonance imaging

Acronym

Effect of EPA/DHA treatment on coronary hyperintense plaque detected by magnetic resonance imaging

Scientific Title

Effect of EPA/DHA treatment on coronary hyperintense plaque detected by non-contrast T1-weighted magnetic resonance imaging

Scientific Title:Acronym

Effect of EPA/DHA treatment on coronary hyperintense plaque detected by magnetic resonance imaging

Region

Japan


Condition

Condition

coronary artery disease with dyslipidemia

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

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.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

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)

Key secondary outcomes

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)


Base

Study type


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation

YES

Institution consideration


Blocking


Concealment

Central registration


Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

2-g group: Subjects will take 2 g per dose of omega-3-acid ethyl esters once daily, immediately after meal.

Interventions/Control_2

4-g group: Subjects will take 2 g per dose of omega-3-acid ethyl esters twice daily, immediately after meal.

Interventions/Control_3

No-treatment group: Subjects will not take omega-3-acid ethyl esters.

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. 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

Key exclusion criteria

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.

Target sample size

150


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Satoshi Yasuda

Organization

National Cerebral and Cardiovascular Center

Division name

Department of Cardiovascular Medicine

Zip code


Address

5-7-1 Fujishirodai, Suita, Osaka Japan

TEL

06-6833-5012

Email

yasuda.satoshi.hp@ncvc.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Teruo Noguchi

Organization

National Cerebral and Cardiovascular Center

Division name

Department of Cardiovascular Medicine

Zip code


Address

5-7-1 Fujishirodai, Suita, Osaka Japan

TEL

06-6833-5012

Homepage URL


Email

tnoguchi@hsp.ncvc.go.jp


Sponsor or person

Institute

Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center

Institute

Department

Personal name



Funding Source

Organization

Takeda Pharmaceutical Co., Ltd.

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

2014 Year 10 Month 10 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

Enrolling by invitation

Date of protocol fixation

2014 Year 05 Month 31 Day

Date of IRB


Anticipated trial start date

2014 Year 12 Month 20 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 10 Month 02 Day

Last modified on

2014 Year 12 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017459


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name