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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03657758
Other study ID # 300027
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
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