Lesional Evaluation of High Risk Patients With Neoatherosclerosis Treated With Rosuvastatin and Eicosapentaenoic Acid Using Optical Coherence Tomography(OCT)[LINK IT TWO]
NCT ID: NCT03657758
Last Updated: 2018-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
75 participants
INTERVENTIONAL
2018-09-17
2021-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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EPA and statin therapy group
After randomization, patients with combination therapy start EPA (1800mg/day) and high dose rosuvastatin (10mg/day) for ９ months.
EPA and rosuvastatin
To take EPA (1800mg/day) and high dose rosuvastatin (10mg/day) for ９ months.
High dose statin therapy group
After randomization, patients with high dose statin therapy start high dose rosuvastatin (10mg/day) for ９ months.
High dose rosuvastatin
To take high dose rosuvastatin (10mg/day) for ９ months.
low dose statin therapy group
After randomization, patients with low dose statin therapy take low dose rosuvastatin (5mg/day) for ９ months.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
ALL
Yes
Sponsors
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Kobe University
INDUSTRY
Responsible Party
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Hiromasa Otake
Senior Lecturer
Locations
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Kobe University Graduate School of Medicine, Department of Cardiology
Kobe, Hyōgo, Japan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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300027
Identifier Type: -
Identifier Source: org_study_id
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