Study Summary
The primary objective of this study 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).
Eligible Conditions
- Atherosclerotic Cardiovascular Disease
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 11 Secondary · Reporting Duration: Approximately 4 years
Approximately 4 years
Time to CHD death
Time to CHD death or myocardial infarction, whichever occurs first
Time to CHD death, myocardial infarction, or urgent coronary revascularization, whichever occurs first
Time to cardiovascular death
Myocardial Infarction
Time to cardiovascular death, myocardial infarction, urgent coronary revascularization, or ischemic stroke, whichever occurs first
Time to coronary revascularization
Time to death by any cause
Time to ischemic stroke
Time to myocardial infarction
Time to urgent coronary revascularization
Baseline and Week 48
Lipoproteins
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
2 Treatment Groups
Olpasiran
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group
6000 Total Participants · 2 Treatment Groups
Primary Treatment: Olpasiran · Has Placebo Group · Phase 3
Olpasiran
Drug
Experimental Group · 1 Intervention: Olpasiran · Intervention Types: DrugPlacebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olpasiran
2020
Completed Phase 2
~320
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 4 years
Who is running the clinical trial?
AmgenLead Sponsor
1,296 Previous Clinical Trials
1,322,818 Total Patients Enrolled
MDStudy DirectorAmgen
838 Previous Clinical Trials
891,919 Total Patients Enrolled
Eligibility Criteria
Age 18 - 85 · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a high level of Lp(a) during screening.
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Conditions
Cancer Related
Treatments