Coronary Artery Disease Clinical Trial
Official title:
Lesional Evaluation of High Risk Patients With Neoatherosclerosis Treated With Rosuvastatin and Eicosapentaenoic Acid Using OCT
This study aim is to evaluate the additional effect of eicosapentaenoic acid and dose up effect of rosuvastatin for neoatherosclerosis in coronary artery disease patients.
Status | Not yet recruiting |
Enrollment | 75 |
Est. completion date | August 31, 2021 |
Est. primary completion date | August 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: 1. over 20 years 2. Patients implanted everolimus-eluting stent(EES) neoatherosccrelosis with neoatherosclerosis by OCT 3. LDL is or less than 100 mg/dl after ingesting 5 mg/day of rosuvastatin Exclusion Criteria: 1. Patients taking omega 3 fatty acid before randomization 2. Patients allergic to rosuvastatin or eicosapentaenoic acid 3. Patients with a history of hemorrhagic stroke 4. Patients taking anti cancer agent 5. Patients undergoing LDL apheresis 6. Patients with severe liver disease or severe kidney disease 7. Patients who conflict with any of the warnings or contraindications listed in the domestic package insert of rosuvastatin 8. Patients who conflict with any of the warnings or contraindications listed in the domestic package insert of eicosapentaenoic acid 9. Patients performed percutaneous coronary intervention with restenosis of target lesion 10. Pregnant women or patients with possibility of Pregnancy or nursing woman |
Country | Name | City | State |
---|---|---|---|
Japan | Kobe University Graduate School of Medicine, Department of Cardiology | Kobe | Hyogo |
Lead Sponsor | Collaborator |
---|---|
Kobe University |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The change in lipid index | mean lipid arc ? lipid length | 9 months | |
Secondary | MACE | Major cerebro-cardiovascular events(Nonfatal stroke, Nonfatal myocardial infarction, cardiovascular death) | 9 months | |
Secondary | The change in minimum lumen area | OCT parameter | 9 months | |
Secondary | The change in average neointimal thickness | OCT parameter | 9 months | |
Secondary | The change in lipid arc | OCT parameter | 9 months | |
Secondary | The change in lipid length | OCT parameter | 9 months | |
Secondary | The change in thin cap fibroatheroma | OCT parameter | 9 months | |
Secondary | The change in macrophage grade | OCT parameter | 9 months | |
Secondary | The change in plaque volume | Near infrared spectroscopy intravascular ultrasound(NIRS-IVUS) parameter | 9 months | |
Secondary | The change in max Lipid-core burden index | NIRS-IVUS parameter | 9 months |
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