Atherosclerotic Cardiovascular Disease
Conditions
Keywords
Atherosclerotic Cardiovascular Disease, ASCVD, AMG 890, Olpasiran
Brief summary
The primary objective of this trial is to compare the effect of treatment with olpasiran, to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants with atherosclerotic cardiovascular disease (ASCVD) and elevated Lipoprotein(a).
Interventions
DRUGPlacebo
Placebo given by subcutaneous injection once every 12 weeks (Q12W).
DRUGOlpasiran
Olpasiran given by subcutaneous injection Q12W.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to ≤ 85 years * Lp(a) ≥ 200 nmol/L during screening * History of ASCVD as evidenced by history of either: * Myocardial infarction (presumed type 1 event due to plaque rupture/erosion) and/or * Coronary revascularization with percutaneous coronary intervention AND at least 1 additional risk factor.
Exclusion criteria
* Severe renal dysfunction * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 x upper limit of normal (ULN), or total bilirubin (TBL) \> 2 x ULN during screening * History of hemorrhagic stroke * History of major bleeding disorder * Planned cardiac surgery or arterial revascularization * Severe heart failure * Current, recent, or planned lipoprotein apheresis * Previously received ribonucleic acid therapy specifically targeting Lp(a)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to CHD death, myocardial infarction, or urgent coronary revascularization, whichever occurs first | Approximately 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Time to cardiovascular death, myocardial infarction, or ischemic stroke, whichever occurs first | Approximately 5 years |
| Time to cardiovascular death, myocardial infarction, urgent coronary revascularization, or ischemic stroke, whichever occurs first | Approximately 5 years |
| Percent change from baseline to Week 48 in Lipoprotein(a) | Baseline and Week 48 |
| Time to myocardial infarction | Approximately 5 years |
| Time to CHD death or myocardial infarction, whichever occurs first | Approximately 5 years |
| Time to urgent coronary revascularization | Approximately 5 years |
| Time to coronary revascularization | Approximately 5 years |
| Time to CHD death | Approximately 5 years |
| Time to cardiovascular death | Approximately 5 years |
| Time to death by any cause | Approximately 5 years |
| Time to ischemic stroke | Approximately 5 years |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, Italy, Japan, Lithuania, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States
Contacts
STUDY_DIRECTORMD
Amgen
Outcome results
None listed