Coronary artery disease
Conditions
Interventions
Sponsors
Study group on treatment of coronary artery disease
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with CAD who took statin over one month and met all following criteria; (1) Patients aged 20 years to 79 years at the time of informed consent (2) Patients given written informed consent CAD is defined as having at least one of the following criteria (1) to (3); (1) History of acute coronary syndrome (acute myocardial infarction or unstable angina) (2) History of coronary revascularization (PCI or CABG) (3) Clinically diagnosed ischemic heart disease and severe coronary artery stenosis (75% or higher according to AHA classification) demonstrated in coronary angiography
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Composite endpoint. 1) Composite event of coronary artery disease Endpoints are the first occurrence of any of the following events. Cardiac sudden death, fatal/non-fatal MI*, unstable angina requiring emergent hospitalization and coronary revascularization, and coronary revascularization based on clinical findings. 2) Composite event of cerebrovascular disorders Endpoints are the first occurrence of any of the following events. 2-1) Fatal/non-fatal stroke, hospitalization due to transient ischemic attack. 2-2) Fatal/non-fatal stroke (2) Event relating to death Occurrence of each following event; 1) All-cause death 2) Cardiovascular death 3) Cardiac death (3) Event relating to cardiac disease Occurrence of each following event; 1) Fatal/non-fatal MI* 2) PCI related MI 3) CABG related MI 4) Stent thrombosis associated with MI 5) Cardiac sudden death 6) Unstable angina requiring emergent hospitalization and coronary revascularization 7) Resuscitation from cardiac arrest 8) Hospitalization due to heart failure 9) New-onset of atrial fibrillation 10) Coronary revascularization (PCI or CABG) 10-1) All coronary revascularization (a) TLR (b) TVR (c) TVR-Remote (d) Non-TVR 10-2) Coronary revascularization based on clinical findings (a) TLR (b) TVR (c) TVR-Remote (d) Non-TVR (4) Events relating to cerebrovascular disorders Occurrence of each following event; 1) Fatal/non-fatal cerebral hemorrhage 2) Fatal/non-fatal stroke 3) TIA requiring hospitalization (5) Other events Occurrence of each following event; 1) Revascularization to peripheral artery disease (PAD) 2) Carotid artery stenting (CAS) or carotid endarterectomy (CEA) 3) Deep vein thrombosis (DVT) or pulmonary thromboembolism (PTE) 4) New occurrence of malignant tumor 5) Progression to dialysis 6) Hemorrhagic event (6) Biomarkers | — |
Countries
Japan
Contacts
Public ContactKumiko Kitagawa
Research Institute for Production Development Secretariat of RESPECT-EPA
Outcome results
None listed