Cardiovascular Disease
Conditions
Keywords
Olpasiran, AMG 890, Coronary heart disease, CHD, Myocardial infarction, Coronary revascularization
Brief summary
The primary objective is to evaluate the effect of olpasiran, compared to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants at risk for a first major cardiovascular event with elevated lipoprotein(a) (Lp\[a\]).
Interventions
DRUGOlpasiran
Olpasiran will be administered via SC injection.
DRUGPlacebo
Placebo will be administered via SC injection.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 105 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥50 years * Lp(a)≥ 200 nmol/L during screening * Multiple atherosclerotic cardiovascular disease risk factors, and/or evidence of atherosclerosis
Exclusion criteria
* Prior acute atherothrombotic event (myocardial infarction, stroke, transient ischemic attack, acute limb ischemia) * Prior or planned arterial revascularization * History of major bleeding disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to CHD Death, Myocardial Infarction, or Urgent Coronary Revascularization, Whichever Occurs First | Up to approximately 6.2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Cardiovascular Death, Myocardial Infarction, or Ischemic Stroke, Whichever Occurs First | Up to approximately 6.2 years | — |
| Time to Cardiovascular Death, Myocardial Infarction, Urgent Coronary Revascularization, or Ischemic Stroke, Whichever Occurs First | Up to approximately 6.2 years | — |
| Percent Change From Baseline to Week 48 Lp(a) Levels | Baseline and Week 48 | — |
| Time to Myocardial Infarction | Up to approximately 6.2 years | — |
| Time to CHD Death or Myocardial Infarction, Whichever Occurs First | Up to approximately 6.2 years | — |
| Time to Urgent Coronary Revascularization | Up to approximately 6.2 years | — |
| Time to Coronary Revascularization | Up to approximately 6.2 years | — |
| Time to CHD Death | Up to approximately 6.2 years | — |
| Time to Cardiovascular Death | Up to approximately 6.2 years | — |
| Time to Death by any Cause | Up to approximately 6.2 years | — |
| Time to Ischemic Stroke | Up to approximately 6.2 years | — |
| Serum Concentration of Olpasiran | Up to Week 48 | — |
| Number of Participants with Treatment Emergent Adverse Events (TEAEs) | Up to approximately 6.2 years | Including serious adverse events and adverse events leading to discontinuation of investigational product. |
Countries
Australia, Canada, United States
Contacts
CONTACTAmgen Call Center
STUDY_DIRECTORMD
Amgen
Outcome results
None listed