NCT03657758

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P25-P50 for phase_4 coronary-artery-disease

Timeline
Completed

Started Sep 2018

Typical duration for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 5, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

September 17, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

September 18, 2018

Status Verified

September 1, 2018

Enrollment Period

2 years

First QC Date

August 31, 2018

Last Update Submit

September 16, 2018

Conditions

Coronary Artery DiseaseAngina Pectoris

Keywords

eicosapentaenoic acidOCTneoatherosclerosis

Outcome Measures

Primary Outcomes (1)

  • The change in lipid index

    mean lipid arc ✕ lipid length

    9 months

Secondary Outcomes (9)

  • MACE

    9 months

  • The change in minimum lumen area

    9 months

  • The change in average neointimal thickness

    9 months

  • The change in lipid arc

    9 months

  • The change in lipid length

    9 months

  • +4 more secondary outcomes

Study Arms (3)

EPA and statin therapy group

ACTIVE COMPARATOR

After randomization, patients with combination therapy start EPA (1800mg/day) and high dose rosuvastatin (10mg/day) for ９ months.

Drug: EPA and rosuvastatin

High dose statin therapy group

ACTIVE COMPARATOR

After randomization, patients with high dose statin therapy start high dose rosuvastatin (10mg/day) for ９ months.

Drug: High dose rosuvastatin

low dose statin therapy group

NO INTERVENTION

After randomization, patients with low dose statin therapy take low dose rosuvastatin (5mg/day) for ９ months.

Interventions

EPA and rosuvastatinDRUG

To take EPA (1800mg/day) and high dose rosuvastatin (10mg/day) for ９ months.

EPA and statin therapy group
High dose rosuvastatinDRUG

To take high dose rosuvastatin (10mg/day) for ９ months.

High dose statin therapy group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kobe University Graduate School of Medicine, Department of Cardiology

Kobe, Hyōgo, 650-0017, Japan

Location

MeSH Terms

Conditions

Coronary Artery DiseaseAngina Pectoris

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Hiromasa Otake, ph.D

CONTACT

+81-78-382-5846hotake@med.kobe-u.ac.jp

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

August 31, 2018

First Posted

September 5, 2018

Study Start

September 17, 2018

Primary Completion

August 31, 2020

Study Completion

August 31, 2021

Last Updated

September 18, 2018

Record last verified: 2018-09

Locations

JP(1)