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

September 16, 2018 updated by: Hiromasa Otake, Kobe University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Hyogo
      • Kobe, Hyogo, Japan, 650-0017
        • Kobe University Graduate School of Medicine, Department of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: EPA and statin therapy group
After randomization, patients with combination therapy start EPA (1800mg/day) and high dose rosuvastatin (10mg/day) for ９ months.
Drug: EPA and rosuvastatin
To take EPA (1800mg/day) and high dose rosuvastatin (10mg/day) for ９ months.
ACTIVE_COMPARATOR: High dose statin therapy group
After randomization, patients with high dose statin therapy start high dose rosuvastatin (10mg/day) for ９ months.
Drug: High dose rosuvastatin
To take high dose rosuvastatin (10mg/day) for ９ months.
NO_INTERVENTION: low dose statin therapy group
After randomization, patients with low dose statin therapy take low dose rosuvastatin (5mg/day) for ９ months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in lipid index
Time Frame: 9 months
mean lipid arc ✕ lipid length
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE
Time Frame: 9 months
Major cerebro-cardiovascular events（Nonfatal stroke, Nonfatal myocardial infarction, cardiovascular death)
9 months
The change in minimum lumen area
Time Frame: 9 months
OCT parameter
9 months
The change in average neointimal thickness
Time Frame: 9 months
OCT parameter
9 months
The change in lipid arc
Time Frame: 9 months
OCT parameter
9 months
The change in lipid length
Time Frame: 9 months
OCT parameter
9 months
The change in thin cap fibroatheroma
Time Frame: 9 months
OCT parameter
9 months
The change in macrophage grade
Time Frame: 9 months
OCT parameter
9 months
The change in plaque volume
Time Frame: 9 months
Near infrared spectroscopy intravascular ultrasound(NIRS-IVUS) parameter
9 months
The change in max Lipid-core burden index
Time Frame: 9 months
NIRS-IVUS parameter
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kobe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 17, 2018

Primary Completion (ANTICIPATED)

August 31, 2020

Study Completion (ANTICIPATED)

August 31, 2021

Study Registration Dates

First Submitted

August 31, 2018

First Submitted That Met QC Criteria

September 4, 2018

First Posted (ACTUAL)

September 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 18, 2018

Last Update Submitted That Met QC Criteria

September 16, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 300027

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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