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Effect of Alirocumab(proprotein convertase subtilisin/kexin type9 inhibitor) and Rosuvastatin or Rosuvastatin alone on lipid core plaques in coronary artery disease evaluated by near-infrared spectroscopy intravascular ultrasound

Effect of Alirocumab(proprotein convertase subtilisin/kexin type9 inhibitor) and Rosuvastatin or Rosuvastatin alone on lipid core plaques in coronary artery disease evaluated by near-infrared spectroscopy intravascular ultrasound - ANTARES

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000031243
Enrollment
30
Registered
2018-04-01
Start date
2018-04-01
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

angina pectoris

Interventions

Alirocumab 75mg/2week+Rosuvastatin 5mg/daily during 9 months Rosuvastatin 10mg/daily alone during 9 months

Sponsors

Kobe University,department of cardiology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: In patients undergoing PCI with ACS or stable angina, stenosis of 25-75% on CAG remained after PCI and maxLCBI(4mm) was over 400 in patients who could analyze NIRS-IVUS images.

Exclusion criteria

Exclusion criteria: Patients who have received one or more doses of anti-PCSK9 monoclonal antibody. Patients who experienced poorly controlled high blood pressure (systolic blood pressure>180 mmHg or diastolic blood pressure>110 mmHg measured more than once) between the time of PCI and randomization. Patients with LDL-Chol value <70 mg/dl. Patients with allergic drug hypersensitivity to drugs to be used. Patients with a history of hemorrhagic stroke. Patients receiving treatment for anticancer drugs. Patients undergoing LDL apheresis. Patients with serious liver and kidney dysfunction. Patients who conflict with any of the warning contraindications listed in the Rosuvastatin national package insert. Patients contradicting the contraindications listed in the Pralient's national package insert. Pregnant women and pregnant or lactating patients. Others Patients judged inappropriate by the doctor in charge of this exam.

Design outcomes

Primary

MeasureTime frame
We investigate the change in the maxLCBI (4 mm) value calculated by NIRS-IVUS test at the time of PCI and treatment evaluation (week 36) in the group of Alirocumab and standard treatment (statin alone).

Secondary

MeasureTime frame
LCBI(lesion), Angle of lipid core, EEM CSA, Lumen CSA, Minimum lumen diameter, Plaque burden, Lesion length

Countries

Japan

Contacts

Public ContactTanimura Kosuke

Kobe University Hospital Cardiology

k.tanimura1006@gmail.com078-382-5846

Outcome results

None listed

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