Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction (OCEAN(a)) - Outcomes Trial

Study Overview
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Brief Summary
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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).

Official Title
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A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Olpasiran on Major Cardiovascular Events in Participants With Atherosclerotic Cardiovascular Disease and Elevated Lipoprotein(a)

Conditions
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Atherosclerotic Cardiovascular Disease

Intervention / Treatment
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* Drug: Placebo
* Drug: Olpasiran


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo will be administered by subcutaneous injection | Drug: Placebo<br>* Placebo given by subcutaneous injection once every 12 weeks (Q12W).<br>|
| Experimental: Olpasiran<br>Olpasiran will be administered by subcutaneous injection | Drug: Olpasiran<br>* Olpasiran given by subcutaneous injection Q12W.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to CHD death, myocardial infarction, or urgent coronary revascularization, whichever occurs first |  | Approximately 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to cardiovascular death, myocardial infarction, or ischemic stroke, whichever occurs first |  | Approximately 4 years | 
| Time to cardiovascular death, myocardial infarction, urgent coronary revascularization, or ischemic stroke, whichever occurs first |  | Approximately 4 years | 
| Percent change from baseline to Week 48 in Lipoprotein(a) |  | Baseline and Week 48 | 
| Time to myocardial infarction |  | Approximately 4 years | 
| Time to CHD death or myocardial infarction, whichever occurs first |  | Approximately 4 years | 
| Time to urgent coronary revascularization |  | Approximately 4 years | 
| Time to coronary revascularization |  | Approximately 4 years | 
| Time to CHD death |  | Approximately 4 years | 
| Time to cardiovascular death |  | Approximately 4 years | 
| Time to death by any cause |  | Approximately 4 years | 
| Time to ischemic stroke |  | Approximately 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atherosclerotic Cardiovascular Disease, ASCVD, AMG 890, Olpasiran