Patients underwent PCI who has history of ischemic stroke
Conditions
Interventions
Administration of ethyl icosapentate/docosahexaenoate combination(4g/day) Duration of administration
2years(minimum)
Non-Administration of ethyl icosapentate/docosahexaenoate combination(4g/day)
Sponsors
Yokohama Shintoshi Neurosurgical Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1) Allergy against ethyl icosapentate/docosahexaenoate 2) Poor controlled diabetes mellitus (HbA1c>10%) 3) History of acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months(stroke is excluded) 4) Either level of aspartate aminotransaminase or alanine aminotransferase exceeds three-fold of the normal limits. 5) eGFR 30 mL/min/1.73 m2 or less (in case of the subjects treated statins, eGFR 60 mL/min/1.73 m2 or less) 1) Allergy against ethyl icosapentate/docosahexaenoate 2) Poor controlled diabetes mellitus (HbA1c>10%) 3) History of acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months(stroke is excluded) 4) Either level of aspartate aminotransaminase or alanine aminotransferase exceeds three-fold of the normal limits. 5) eGFR 30 mL/min/1.73 m2 or less (in case of the subjects treated statins, eGFR 60 mL/min/1.73 m2 or less) 6) Symptomatic (NYHA III or IV) congestive heart failure 7) Malignancies or other diseases with poor prognosis 8) Pregnant 9) Severe infection/trauma 10) Subjects who statins treatment is recommended by Guideline of Japan Atherosclerotic Society 2012. 11) Subjects whose doctor in charge do not agree to join the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (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
| Measure | Time frame |
|---|---|
| (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 | — |
Countries
Japan
Contacts
Public ContactKei Kawai
Yokohama Shintoshi Neurosurgical Hospital Department of Cardiology
Outcome results
None listed