Back to Search Results
Recruitment Complete
Sponsor ID
20180244

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

Sponsor ID
20180244
Clinicaltrials.gov ID
NCT05581303
EUCTIS ID
N/A
EudraCT ID
2022-501608-85
Contact Us

Study Details

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).

Additional Study Details

Phase
Phase 3
Product
Olpasiran
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
7297
Additional Study Details

Protocol Summary

Primary Outcome Measures

Time to CHD death, myocardial infarction, or urgent coronary revascularization, whichever occurs first

Timeframe: Approximately 5 years

Secondary Outcome Measures

Time to cardiovascular death, myocardial infarction, or ischemic stroke, whichever occurs first

Timeframe: Approximately 5 years

Time to cardiovascular death, myocardial infarction, urgent coronary revascularization, or ischemic stroke, whichever occurs first

Timeframe: Approximately 5 years

Percent change from baseline to Week 48 in Lipoprotein(a)

Timeframe: Baseline and Week 48

Time to myocardial infarction

Timeframe: Approximately 5 years

Time to CHD death or myocardial infarction, whichever occurs first

Timeframe: Approximately 5 years

Time to urgent coronary revascularization

Timeframe: Approximately 5 years

Time to coronary revascularization

Timeframe: Approximately 5 years

Time to CHD death

Timeframe: Approximately 5 years

Time to cardiovascular death

Timeframe: Approximately 5 years

Time to death by any cause

Timeframe: Approximately 5 years

Time to ischemic stroke

Timeframe: Approximately 5 years

Locations

Location
Status
Contact Us
Location
Royal Prince Alfred Hospital
Camperdown, NSW, Australia, 2050
Status
Recruiting
Location
Concord Repatriation General Hospital
Concord, NSW, Australia, 2139
Status
Recruiting
Location
Dr Heart Pty Ltd
Woolloongabba, QLD, Australia, 4102
Status
Recruiting
Location
Advara HeartCare Wesley
Auchenflower, QLD, Australia, 4066
Status
Recruiting
Location
Royal Brisbane and Womens Hospital
Herston, QLD, Australia, 4029
Status
Recruiting
Location
Advara HeartCare Leabrook
Leabrook, SA, Australia, 5068
Status
Recruiting
Showing {first} - {last} of {total} Results
Study Info
Age
18 - 85 Years
Condition
  • Cardiovascular Disease
    • Sex
    All
    Trial Dates
    Dec 2022 - Mar 2028
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    • Age 18 to ≤ 85 years • Lp(a) ≥ 200 nmol/L during screening • History of ASCVD as evidenced by history of either: o Myocardial infarction (presumed type 1 event due to plaque rupture/erosion) and/or o 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)