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Lesional evaluation of high-risk patients with neoatherosclerosis treated with rosuvastatin and eicosapentaenoic acid using OCT and NIRS IVUS

Lesional evaluation of high-risk patients with neoatherosclerosis treated with rosuvastatin and eicosapentaenoic acid using OCT and NIRS IVUS - LINK IT two

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000033335
Enrollment
75
Registered
2018-09-01
Start date
2018-09-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ischemic heart disease

Interventions

36weeks 10 mg/day of rosuvastatin 1800 mg/day of eicosapentaenoic acid 36weeks 5 mg/day of rosuvastatin 1800 mg/day of eicosapentaenoic acid 36weeks 5 mg/day of rosuvastatin

Sponsors

Kobe University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1 over 20 years 2 Patients implanted EES neoatherosccrelosis with NA by OCT 3 LDL is or less than 100 mg/dl after ingesting 5 mg/day of rosuvastatin

Exclusion criteria

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 perfomed PCI with restenosis of target lesion 10 Pregnant women or patients with possibilty of Pregnancy or nursing woman

Design outcomes

Primary

MeasureTime frame
lipid index

Secondary

MeasureTime frame
1 Major adverse cardiac event 2 follow up OCT data Minimum lumen area, average neointimal thickness, lipid arc, lipid length, TCFA, macrophage grade 3 NIRS IVUS LCBI 4mm, plaque volume

Countries

Japan

Contacts

Public ContactShinsuke Nakano

Kobe University Hospital Cardiology

dqswx303@yahoo.co.jp078-382-5846

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026