Angina Pectoris, Coronary Artery Disease
Conditions
Keywords
eicosapentaenoic acid, OCT, neoatherosclerosis
Brief summary
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.
Detailed description
Eicosapentaenoic acid and statin therapy prevents cardiovascular events. However, the impact of these treatment in patients with in-stent neoatherosclerosis has not been clarified. So, the investigators conducted LINK IT study. This study showed that eicosapentaenoic acid(EPA) and rosuvastatin therapy improve lipid index in patients compared with rosuvastatin alone therapy. However, it was insufficient to directly evaluate the efficacy of additional effect of EPA for neoatherosclerosis. Because, statin dose of two groups was different and type of stent was variety. Therefore, the investigators designed a new prospective, randomized OCT study. The OCT operators randomly assigned 75 patients who were detected neoatherosclerosis on follow-up OCT examination after implanted everolimus eluting stent to three groups; 5mg/day of rosuvastatin therapy (low dose statin therapy group) or 10mg/day of rosuvastatin therapy (high dose statin therapy group) or 10mg/day of rosuvastatin and 1800mg/day of eicosapentaenoic acid therapy (EPA and statin therapy group). Serial coronary angiography and OCT were performed at 9 months after baseline OCT procedure. 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 by comparing 3 groups.
Interventions
DRUGEPA and rosuvastatin
To take EPA (1800mg/day) and high dose rosuvastatin (10mg/day) for ９ months.
To take high dose rosuvastatin (10mg/day) for ９ months.
Sponsors
Kobe University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in lipid index | 9 months | mean lipid arc ✕ lipid length |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MACE | 9 months | Major cerebro-cardiovascular events（Nonfatal stroke, Nonfatal myocardial infarction, cardiovascular death) |
| The change in minimum lumen area | 9 months | OCT parameter |
| The change in average neointimal thickness | 9 months | OCT parameter |
| The change in lipid arc | 9 months | OCT parameter |
| The change in lipid length | 9 months | OCT parameter |
| The change in macrophage grade | 9 months | OCT parameter |
| The change in plaque volume | 9 months | Near infrared spectroscopy intravascular ultrasound(NIRS-IVUS) parameter |
| The change in max Lipid-core burden index | 9 months | NIRS-IVUS parameter |
| The change in thin cap fibroatheroma | 9 months | OCT parameter |
Countries
Japan
Contacts
Primary ContactHiromasa Otake, ph.D
Outcome results
None listed