Efficacy of Alirocumab for Thin-cap fibroatheroma in patients with coronary artery disease estImated by optical coherence tomography trial.

Efficacy of Alirocumab for Thin-cap fibroatheroma in patients with coronary artery disease estImated by optical coherence tomography trial. - ALTAIR trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000029533

Enrollment

Registered

2017-10-13

Start date

2017-09-26

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

vulnerable plaque in patients with coronary artery disease

Interventions

Patients in the alirocumab arm will receive subcutaneous alirocumab 75 mg every 2 weeks (Q2W) in addition to statin therapy (rosuvastatin 10 mg/day). Patients in the standard-of-care arm will recei

70 mg/dL

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ALTAIR employs the following eligibility criteria: 1: Patients who underwent PCI for ACS or stable coronary heart disease 2: Patients who have been treated stain therapy or who have been started statin therapy after PCI 3: Patients who have been detected TCFA by OCT at PCI 4: Patients aged more than or equal 20 years old at PCI 5: Patients who agree to be enrolled in the trial giving signed written informed consent

Exclusion criteria

Exclusion criteria: Exclusion criteria are follows; 1: Patients who have been treated previously with at least one dose of any anti-PCSK9 monoclonal antibody 2: Patients had uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg) between the time of PCI and randomization visit 3: Patients with LDL-C <70 mg/dL 4: Known hypersensitivity to alirocumab or rosuvastatin 5: Known history of hemorrhagic stroke 6: Currently under treatment for cancer 7: Patients on lipoprotein apheresis 8: Patients with severe liver or renal dysfunction 9: All contraindications to rosuvastatin as displayed in the respective national product labeling for these treatments 10: All contraindications to alirocumab as displayed in the respective national product labeling for these treatments 11: Pregnant or breast-feeding women 12: Considered by the investigator as inappropriate for this study for any reason

Design outcomes

Primary

Measure	Time frame
the difference of fibrous cap thickness from baseline	—

Countries

Japan

Contacts

Public ContactYoichiro Sugizaki

Kobe University Graduate School of Medicine Division of Cardiovascular Medicine

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

Outcome results

None listed

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