Brief 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).
Brief Title
Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction (OCEAN(a)) - Outcomes Trial
Completion Date
Completion Date Type
Estimated
Conditions
Atherosclerotic Cardiovascular Disease
Eligibility Criteria
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)
* 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)
Inclusion Criteria
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.
* 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.
Gender
All
Gender Based
false
Keywords
Atherosclerotic Cardiovascular Disease
ASCVD
AMG 890
Olpasiran
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
85 Years
Minimum Age
18 Years
NCT Id
NCT05581303
Org Class
Industry
Org Full Name
Amgen
Org Study Id
20180244
Overall Status
Active, not recruiting
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
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)
Primary Outcomes
Outcome Measure
Time to CHD death, myocardial infarction, or urgent coronary revascularization, whichever occurs first
Outcome Time Frame
Approximately 4 years
Secondary Outcomes
Outcome Time Frame
Approximately 4 years
Outcome Measure
Time to cardiovascular death, myocardial infarction, or ischemic stroke, whichever occurs first
Outcome Time Frame
Approximately 4 years
Outcome Measure
Time to cardiovascular death, myocardial infarction, urgent coronary revascularization, or ischemic stroke, whichever occurs first
Outcome Time Frame
Baseline and Week 48
Outcome Measure
Percent change from baseline to Week 48 in Lipoprotein(a)
Outcome Time Frame
Approximately 4 years
Outcome Measure
Time to myocardial infarction
Outcome Time Frame
Approximately 4 years
Outcome Measure
Time to CHD death or myocardial infarction, whichever occurs first
Outcome Time Frame
Approximately 4 years
Outcome Measure
Time to urgent coronary revascularization
Outcome Time Frame
Approximately 4 years
Outcome Measure
Time to coronary revascularization
Outcome Time Frame
Approximately 4 years
Outcome Measure
Time to CHD death
Outcome Time Frame
Approximately 4 years
Outcome Measure
Time to cardiovascular death
Outcome Time Frame
Approximately 4 years
Outcome Measure
Time to death by any cause
Outcome Time Frame
Approximately 4 years
Outcome Measure
Time to ischemic stroke
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
85
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Leandro Slipczuk Bustamante
Investigator Email
lslipczukb@montefiore.org