Prospective Observational study for Lesion of neoatherosclerosis; the efficacy of Alirocumab for the neoatherosclerosis Reaction Investigated by Serial optical coherence tomography

Prospective Observational study for Lesion of neoatherosclerosis; the efficacy of Alirocumab for the neoatherosclerosis Reaction Investigated by Serial optical coherence tomography - POLARIS study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000029207

Enrollment

Registered

2017-09-21

Start date

2018-01-01

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

neoatherosclerosis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) The age at the time of consent acquisition is 20 years old or over. (2) OCT Images that can be analyzed are obtained, and neoatherosclerosis existed in drug eluting stent (3) lipid lowering therapy with rosuvastatin 10 mg or rosuvastatin 10 mg and aliclumab is performed. (4) Baseline OCT was scheduled to be revisited within 6 to 12 months, or already performed. (5) Document consent has been obtained from the subject person to this research.

Exclusion criteria

Exclusion criteria: (1) Patients who have received treatment with PCSK 9 inhibitor in the past (2) Patients whose treatment was interrupted before follow-up catheterization during the observation period (3) Patients underwent LDL apheresis. (4) In the case that the researchers judges it as inappropriate as the object of this research.

Design outcomes

Primary

Measure	Time frame
Exploratory research for the findings of optical coherence tomography after nine months	—

Countries

Japan

Contacts

Public ContactSatoru Sasaki

Kobe University Graduate School of Medicine Division of Cardiovascular Medicine, Department of Internal Medicine

strsasaki@hotmail.co.jp078-382-5846

Outcome results