Cardiovascular Disease
Conditions
Interventions
Experimental: Olpasiran
Participants will receive olpasiran subcutaneously (SC) once every 12 weeks (Q12W).
Interventions: Drug: Olpasiran
Placebo Comparator: Placebo
Participants will receive pla
Sponsors
Matsumoto Hiroki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 35 to = 200 nmol/L during screening. 3. Angiographic evidence of coronary artery disease in at least one major epicardial vessel on screening CCTA. 4. History of myocardial infarction (presumed type 1 event due to plaque rupture/erosion) and/or coronary revascularization by percutaneous coronary intervention.
Exclusion criteria
Exclusion criteria: 1. History of coronary artery bypass graft (CABG). 2. Moderate to severe renal dysfunction. 3. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 x upper limit of normal (ULN), or total bilirubin (TBL) > 2 x ULN during screening. 4. History of hemorrhagic stroke. 5. History of major bleeding disorder. 6. Planned cardiac surgery or arterial revascularization. 7. Severe heart failure. 8. Current, recent, or planned lipoprotein apheresis. 9. Previously received ribonucleic acid therapy specifically targeting Lp(a).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in NCP Volume from Baseline to Week 72 [Time Frame: Baseline to Week 72] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in Low Attenuation Plaque Volume from Baseline to Week 72 [Time Frame: Baseline to Week 72] 2. Change in Total Plaque Volume from Baseline to Week 72 [Time Frame: Baseline to Week 72] 3. Change in Calcified Plaque Volume from Baseline to Week 72 [Time Frame: Baseline to Week72] 4. Number of Participants with Treatment-emergent Adverse Events (TEAEs) [Time Frame: Up to Week 74] | — |
Countries
Australia, Canada, China, Denmark, France, Germany, Italy, Japan, Netherlands, Spain, United States
Contacts
Public ContactContact Local
Amgen K.K.
Outcome results
None listed