The AQUAMARINE EPA/DHA Study

Not Applicable

• Conditions: Coronary heart disease; D003327

• Registration Number: JPRN-jRCTs051180125
• Lead Sponsor: Yasuda Satosi

Brief Summary

The effect of 1-year administration of omega-3 fatty acid (2 doses) on PMR of coronary high risk plaques evaluated by cardiac MRI was not verified compared to no treatment group.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-01-22
• Study Start: 2019-03-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

Subjects must meet all of the following 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) or invasive coronary angiography (CAG).
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 100 mg/dL at the screening test
6.Age less 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

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.Clinically apparent impairment of renal function
5.Presence of bleeding (e.g., hemophilia, capillary fragility, gastrointestinal tract ulcer, urinary tract bleeding, hemoptysis, vitreous hemorrhage)
6.History of hypersensitivity to any component of the investigational product
7.Other patients who are inappropriate for participation in this study in the opinion of the principal investigator or investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified