Randomized trial for Evaluation in Secondary Prevention Efficacy of Combination Therapy - Statin and Eicosapentaenoic Acid

Phase 4

Completed

• Conditions: Coronary artery disease

• Registration Number: JPRN-UMIN000012069
• Lead Sponsor: Study group on treatment of coronary artery disease

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-21
• Study Completion: 2021-10-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 3900

Inclusion Criteria

Not provided

Exclusion Criteria

Patients who meet one of the following criteria; (1) Patients on dialysis (2) Patients with serious hepatic disease (3) Patients with active malignant tumor (4) Patients for whom coronary angiography or coronary revascularization is scheduled but not yet conducted (5) Patients with severe heart failure (LVEF<30% or NYHA class 3 or 4 according to NYHA classification) (6) Patients who experienced acute coronary syndrome (acute myocardial infarction or unstable angina) within three month at the time of informed consent (7) Patients who received coronary revascularization (PCI or CABG) within three month at the time of informed consent (8) Patients with inadequately controlled diabetes mellitus[HbA1c (JDS): 8.0% or more, HbA1c (NGSP): 8.4% or more] (9) Patients with secondary dyslipidemia associated with (a) nephrotic syndrome, (b) hypothyroidism, (c) Cushing syndrome and (d) other diseases, patients with drug-induced dyslipidemia such as that caused by steroid hormone, or patients receiving EPA (including OTC drugs) or EPA/DHA, or having received such drug within previous 1 month at the time of informed consent (10) Patients having active bleeding or bleeding tendency (11) Patients with a history of adverse reaction to EPA (12) Patients participating in other clinical trial (13) Pregnant women, possibly pregnant women, or women during lactation (14) Other patients who, in the opinion of the participating physician, are not eligible

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoints are the first occurrence of any of the following cardiovascular events. Cardiovascular death, non-fatal myocardial infarction (MI)*, non-fatal cerebral infarction, unstable angina requiring emergent hospitalization and coronary revascularization, and coronary revascularization based on clinical findings. * indicates not including percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) related MI.