Lesional Evaluation of High Risk Patients With Neoatherosclerosis Treated With Rosuvastatin and Eicosapentaenoic Acid Using Optical Coherence Tomography(OCT)[LINK IT TWO]

Kobe University

Status and phase: Unknown; Phase 4

Conditions: Coronary Artery Disease; Angina Pectoris

Treatments: Drug: EPA and rosuvastatin; Drug: High dose rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03657758

300027

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

EPA and statin therapy group

Active Comparator group

Description:

After randomization, patients with combination therapy start EPA (1800mg/day) and high dose rosuvastatin (10mg/day) for ９ months.

Treatment:

Drug: EPA and rosuvastatin

High dose statin therapy group

Active Comparator group

Description:

After randomization, patients with high dose statin therapy start high dose rosuvastatin (10mg/day) for ９ months.

Treatment:

Drug: High dose rosuvastatin

low dose statin therapy group

No Intervention group

Description:

After randomization, patients with low dose statin therapy take low dose rosuvastatin (5mg/day) for ９ months.