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OCEAN(a)-Outcomes – Olpasiran trials of Cardiovascular Events And LipoproteiN(a) reduction – Outcomes trial
EU CTIS ID: 2022-501608-85-00
What this study is testing
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 subjects with atherosclerotic cardiovascular disease (ASCVD) and elevated Lp(a)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subject has provided informed consent prior to initiation of any study specific activities/procedures
- Age 18 to ≤ 85 years (or ≥ legal age within the country if it is older than 18 years) at signing of informed consent
- Lp(a)≥ 200 nmol/L during screening by central laboratory • At least ≥ 2 weeks of stable, and optimized lipid-lowering therapy consistent with regional/local clinical practice guidelines according to investigator’s judgment prior to Screening Lp(a).
- History of ASCVD as evidenced by history of either: • Myocardial infarction (MI) (presumed type 1 event due to plaque rupture/erosion) and/or • Coronary revascularization by percutaneous coronary intervention (PCI)
You likely can't join if
- Severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 by central laboratory during screening
- 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 (for example: hemophilia, von Willebrand disease, clotting factor deficiencies, etc)
- Major cardiovascular event (eg, myocardial infarction, unstable angina, PCI, coronary artery bypass graft, or stroke) within 4 weeks prior to Lp(a) screening or during screening
- Planned cardiac surgery or arterial revascularization
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Canada
- Hong Kong
- Taiwan
- Australia
- Brazil
- China
- Korea, Republic of
- Japan
- Mexico
- Argentina
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Canada; Hong Kong; Taiwan; Australia; Brazil and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.