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

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ClinicalTrials.gov Identifier: NCT03657758
Recruitment Status : Unknown
Verified September 2018 by Hiromasa Otake, Kobe University.
Recruitment status was:  Not yet recruiting
First Posted : September 5, 2018
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Hiromasa Otake, Kobe University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Angina Pectoris Drug: EPA and rosuvastatin Drug: High dose rosuvastatin Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lesional Evaluation of High Risk Patients With Neoatherosclerosis Treated With Rosuvastatin and Eicosapentaenoic Acid Using OCT
Estimated Study Start Date : September 17, 2018
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. The change in lipid index [ Time Frame: 9 months ]
    mean lipid arc ✕ lipid length


Secondary Outcome Measures :
  1. MACE [ Time Frame: 9 months ]
    Major cerebro-cardiovascular events（Nonfatal stroke, Nonfatal myocardial infarction, cardiovascular death)

  2. The change in minimum lumen area [ Time Frame: 9 months ]
    OCT parameter

  3. The change in average neointimal thickness [ Time Frame: 9 months ]
    OCT parameter

  4. The change in lipid arc [ Time Frame: 9 months ]
    OCT parameter

  5. The change in lipid length [ Time Frame: 9 months ]
    OCT parameter

  6. The change in thin cap fibroatheroma [ Time Frame: 9 months ]
    OCT parameter

  7. The change in macrophage grade [ Time Frame: 9 months ]
    OCT parameter

  8. The change in plaque volume [ Time Frame: 9 months ]
    Near infrared spectroscopy intravascular ultrasound(NIRS-IVUS) parameter

  9. The change in max Lipid-core burden index [ Time Frame: 9 months ]
    NIRS-IVUS parameter


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03657758


Contacts
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Contact: Hiromasa Otake, ph.D +81-78-382-5846 hotake@med.kobe-u.ac.jp

Locations
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Japan
Kobe University Graduate School of Medicine, Department of Cardiology
Kobe, Hyogo, Japan, 650-0017
Contact: Hiromasa Otake, ph.D    +81-78-382-5846    hotake@med.kobe-u.ac.jp   
Sponsors and Collaborators
Kobe University
More Information
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Responsible Party: Hiromasa Otake, Senior Lecturer, Kobe University
ClinicalTrials.gov Identifier: NCT03657758    
Other Study ID Numbers: 300027
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hiromasa Otake, Kobe University:
eicosapentaenoic acid
OCT
neoatherosclerosis
Additional relevant MeSH terms:
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Coronary Artery Disease
Angina Pectoris
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Chest Pain
 Pain
Neurologic Manifestations
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors