- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03657758
Lesional Evaluation of High Risk Patients With Neoatherosclerosis Treated With Rosuvastatin and Eicosapentaenoic Acid Using Optical Coherence Tomography(OCT)[LINK IT TWO]
Lesional Evaluation of High Risk Patients With Neoatherosclerosis Treated With Rosuvastatin and Eicosapentaenoic Acid Using OCT
Study Overview
Status
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
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Hiromasa Otake, ph.D
- Phone Number: +81-78-382-5846
- Email: hotake@med.kobe-u.ac.jp
Study Locations
-
-
Hyogo
-
Kobe, Hyogo, Japan, 650-0017
- Kobe University Graduate School of Medicine, Department of Cardiology
-
Contact:
- Hiromasa Otake, ph.D
- Phone Number: +81-78-382-5846
- Email: hotake@med.kobe-u.ac.jp
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- over 20 years
- Patients implanted everolimus-eluting stent(EES) neoatherosccrelosis with neoatherosclerosis by OCT
- LDL is or less than 100 mg/dl after ingesting 5 mg/day of rosuvastatin
Exclusion Criteria:
- Patients taking omega 3 fatty acid before randomization
- Patients allergic to rosuvastatin or eicosapentaenoic acid
- Patients with a history of hemorrhagic stroke
- Patients taking anti cancer agent
- Patients undergoing LDL apheresis
- Patients with severe liver disease or severe kidney disease
- Patients who conflict with any of the warnings or contraindications listed in the domestic package insert of rosuvastatin
- Patients who conflict with any of the warnings or contraindications listed in the domestic package insert of eicosapentaenoic acid
- Patients performed percutaneous coronary intervention with restenosis of target lesion
- Pregnant women or patients with possibility of Pregnancy or nursing woman
Study Plan
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.
|
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.
|
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
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Pain
- Neurologic Manifestations
- Coronary Disease
- Chest Pain
- Coronary Artery Disease
- Angina Pectoris
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Rosuvastatin Calcium
Other Study ID Numbers
- 300027
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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