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

Phase 4

• Conditions: Coronary Artery Disease; Angina Pectoris
• Interventions: Drug: EPA and rosuvastatin; Drug: High dose rosuvastatin

• Registration Number: NCT03657758
• Lead Sponsor: Kobe University

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.

Study Timeline

• Study First Submitted: 2018-08-31
• Status Verified: 2018-09
• Study First Submitted QC: 2018-09-04
• Study First Posted: 2018-09-05
• Last Update Submitted: 2018-09-16
• Study Start: 2018-09-17
• Last Update Posted: 2018-09-18
• Primary Completion: 2020-08-31
• Study Completion: 2021-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The change in lipid index	9 months	mean lipid arc ✕ lipid length

Secondary Outcome Measures

Name	Time	Method
The change in minimum lumen area	9 months	OCT parameter
The change in lipid length	9 months	OCT parameter
The change in thin cap fibroatheroma	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
MACE	9 months	Major cerebro-cardiovascular events（Nonfatal stroke, Nonfatal myocardial infarction, cardiovascular death)
The change in average neointimal thickness	9 months	OCT parameter
The change in lipid arc	9 months	OCT parameter
The change in max Lipid-core burden index	9 months	NIRS-IVUS parameter

Trial Locations

Locations (1)

Kobe University Graduate School of Medicine, Department of Cardiology; 🇯🇵 Kobe, Hyogo, Japan