coronary artery disease
Conditions
Interventions
None listed
Sponsors
Kobe University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: This study is a single-centre, randomised, open-label, parallel-group study evaluating the effect of alirocumab on vulnerable plaques in coronary artery disease using optical coherence tomography (reference number: C180045, clinical trial registration number: UMIN000029533) in patients enrolled in the study, who meet all the following selection criteria Patients who meet all of the following selection criteria and do not meet any of the exclusion criteria will be included. Selection criteria (i) Patients undergoing PCI for CAD. (ii) Patients who were on statin therapy before PCI or started statin therapy after PCI. (iii) Patients with an OCT image available for analysis at the time of PCI and with fragile plaques in the non-responsible lesion (iv) Patients with an OCT image available for analysis at 34-38 weeks after PCI (v) Patients aged 20 years or older at the time of PCI.
Exclusion criteria
Exclusion criteria: Exclusion criteria. (i) Patients who have received at least one anti-PCSK9 monoclonal antibody prior to PCI. (ii) Patients who failed to continue statin monotherapy or combination therapy with a PCSK9 inhibitor and a statin after PCI (iii) Patients with severe hepatic and renal dysfunction (iv) Patients who have requested not to participate in the study at the time of the opportunity to refuse (v) Other cases in which the study investigator considers the subject to be inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount of change in fibrous capsule thickness of plaques observed on OCT examination by AI at the time of PCI and at the time of treatment assessment in the alirocumab and standard of care (statin alone) groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in lipid plaque volume observed at the time of PCI and at the time of AI OCT during treatment assessment in the alirocumab and standard of care (statin alone) groups Change in LCR observed by OCT with alirocumab versus standard of care (statin alone) at the time of PCI and AI at the time of treatment assessment. | — |
Countries
Japan
Contacts
Public ContactTetsuya Yamamoto
Kobe University Graduate School of Medicine Division of Cardiovascular Medicine, Department of Internal Medicine
Outcome results
None listed