Prospective, randomized, open-label, clinical pilot trial comparing the effects of ethyl icosapentate/docosahexaenoate combination on coronary artery lesion and MACCE

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2014
INTERVENTION: Administration of ethyl icosapentate/docosahexaenoate combination(4g/day) Duration of administration; 2years(minimum) Non‐Administration of ethyl icosapentate/docosahexaenoate combination(4g/day) CONDITION: Patients underwent PCI who has history of ischemic stroke PRIMARY OUTCOME: (1). MACCE(death from coronary artery disease, nonfatal AMI, AP, revasculization); (2). Charasteristics of coronary lesion(number of lesion, calcification, bifurcated lesion and SYNTAX score) SECONDARY OUTCOME: (1) Cerebrovascular events(recurrence of ischemic stroke, hemorrhagic stroke); (2) Serum Lipids; (3) HDL Function(Cholesterol efflux, anti‐inflammatory properties, endothelial function); (4) Markers of cognitive function(MMSE); (5) OCT findings(neointimal coverage for stent struts), restenosis/new lesion; (6) Markers of diabetes mellitus(HbA1c, Fasting blood glucose, glycoalbumin); (7) Markers of obesity(adiponectin); (8) Inflammatory markers(High‐sensitive CRP, MCP‐1); (9) Oxidative‐stress markers(MDA‐LDL, EC‐SOD, 8‐OHDG); (10) Markers of early nephropathy(albumin, creatinine, L‐FABP); (11) Uric acid in blood/urine ; (12) Abdominal girth, body height, body weight; (13) Blood pressure, heart rate(home/clinic); (14) ABI; (15) MCG INCLUSION CRITERIA: 1) Subjects with fasting serum triglycerides levels>150mg/dL, or HDL‐C levels<40/50 mg/dl (male/female) or LDL‐C levels>100mg 2) Subjects with ischemic stroke. 3) Subjects with coronary artery disease candidate for PCI 4) Outpatients 5) Subjects who gave written informed consent
Epistemonikos ID: 19f0e5446380b7df440a9750529872f3c35fe977
First added on: Aug 23, 2024