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

Coronary Artery Disease Clinical Trial

Official title:

Lesional Evaluation of High Risk Patients With Neoatherosclerosis Treated With Rosuvastatin and Eicosapentaenoic Acid Using OCT

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03657758
• Other study ID #: 300027
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: September 17, 2018
• Est. completion date: August 31, 2021

Study information

• Verified date: September 2018
• Source: Kobe University
• Contact: Hiromasa Otake, ph.D
• Phone: +81-78-382-5846
• Email: hotake[@]med.kobe-u.ac.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Angina Pectoris
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• EPA and rosuvastatin
To take EPA (1800mg/day) and high dose rosuvastatin (10mg/day) for 9 months.
• High dose rosuvastatin
To take high dose rosuvastatin (10mg/day) for 9 months.

Locations

Country	Name	City	State
Japan	Kobe University Graduate School of Medicine, Department of Cardiology	Kobe	Hyogo

Sponsors (1)

Lead Sponsor	Collaborator
Kobe University

Country where clinical trial is conducted

Japan, 

Outcome

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