Phase 3 Study of Olpasiran on Cardiovascular Events and Lipoprotein(a) Reduction [OCEAN(a)-Outcomes]
Research type
Research Study
Full title
A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Olpasiran on Major Cardiovascular Events in Patients with Atherosclerotic Cardiovascular Disease and Elevated Lipoprotein (a)
IRAS ID
1006924
Contact name
Matthew Rodaway
Contact email
Sponsor organisation
Amgen Inc.
Eudract number
2022-501608-85
Clinicaltrials.gov Identifier
Research summary
This study is being done to learn more about the investigational product in people with cardiovascular disease and elevated Lp(a). Lipoprotein(a) or Lp(a), for short, is a protein which transports cholesterol, a fatty substance, in the blood. There are two main types of lipoprotein: high-density lipoprotein (HDL) cholesterol, which is often referred to as good cholesterol, and low-density lipoprotein (LDL), or bad, cholesterol. Lp(a) has been referred to as ‘LDL with Velcro’, because it’s wrapped in a sticky protein that can easily block artery walls. Lp(a) also interferes with clotting of the blood. Both of these factors increase the risk of heart disease and stroke, and the higher a persons Lp(a) levels, the greater the risk. Elevated plasma Lp(a) has been identified as a strong risk factor for the development and progression of atherosclerotic cardiovascular disease. High Lp(a) levels are seen in people of all races, ethnicities and ages, as well as males and females. However, as well as running in families, high Lp(a) levels are also more common in women and black people.
The aim of this research is to see if the investigational product reduces cardiovascular events (such as coronary heart disease death, myocardial infarction, or urgent coronary revascularisation), lowers Lp(a), and whether it causes any side effects.
In this study participants are treated with the investigational product or placebo.REC name
East Midlands - Derby Research Ethics Committee
REC reference
23/EM/0026
Date of REC Opinion
2 Oct 2023
REC opinion
Further Information Favourable Opinion