Phase 3 Study of Olpasiran in Cardiovascular Events-OCEAN(a)-PreEvent
Research type
Research Study
Full title
A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing Olpasiran Use to Prevent First Major Cardiovascular Events in Participants with Elevated Lipoprotein(a)
IRAS ID
1012117
Contact name
Matthew Rodaway
Contact email
Sponsor organisation
Amgen Inc
Eudract number
2025-520554-11
Research summary
This main research study is being done to learn more about the study product in people with elevated Lp[a], and risk factors for ASCVD and/or evidence of cholesterol plaques in the arteries. Lipoprotein(a) (also known as Lp “little a” and Lp(a)) is a sticky particle that carries cholesterol in the blood. High levels of Lp(a) can increase the chance of plaques building up in the arteries. Atherosclerotic cardiovascular disease (ASCVD) occurs when there is cholesterol or other fatty build-up (plaques) on the walls of the blood vessels (arteries). If patients have elevated Lp(a) levels and risk factors for ASCVD and/or evidence of ASCVD, this means they may have a higher risk of new heart or blood vessel disease events.
The study is being done primarily to see if olpasiran (the study product) reduces the risk of having a cardiovascular event such as heart attack, an urgent procedure to improve blood flow through the coronary (heart) vessel or death due to heart disease and to understand if the study product causes any side effects and how well it is tolerated.
This study is a combined study that will also include an additional part, the evaluation of a test that measures Lp(a) in human samples. This additional evaluation is called the Performance Study. It is run alongside the main study. It will see if the Lp(a) test can be useful and safe to identify people who have high levels of Lp(a) and could receive treatment with the study product.
In this study participants are treated with the study product or placebo.REC name
West of Scotland REC 1
REC reference
25/WS/0097
Date of REC Opinion
11 Dec 2025
REC opinion
Further Information Favourable Opinion