This study focuses on people with Cardiovascular Disease who have elevated levels of lipoprotein(a), a substance in the blood that can increase the risk of heart problems. The research examines a medication called olpasiran to determine if it can help prevent first-time major heart events in people who have never experienced them before.
The study tests whether olpasiran is more effective than a placebo in reducing the risk of serious heart-related events. These events include coronary heart disease death, myocardial infarction (heart attack), and emergency procedures to restore blood flow to the heart. The medication is being studied specifically in people who have high levels of lipoprotein(a) in their blood and are considered at risk for heart problems.
During the study, participants will receive either olpasiran or a placebo while continuing their usual heart medications. The study will track any heart-related events that occur and measure how the treatment affects the amount of lipoprotein(a) in the blood. This research is part of a larger program called OCEAN(a)-PreEvent, which aims to better understand how to prevent first-time heart problems in people with high lipoprotein(a) levels.
1Initial assessment
Your lipoprotein(a) levels will be measured through a blood test at a central laboratory
The test will confirm if your levels are ≥ 200 nmol/L, which is required for participation
Your current heart health and risk factors for heart disease will be evaluated
2Random group assignment
You will be randomly assigned to receive either olpasiran (the study medication) or a placebo (inactive substance)
Neither you nor your doctor will know which treatment you are receiving during the study
3Treatment period
The study will continue until 2031
You will maintain your current heart medications throughout the study
Your lipoprotein(a) levels will be measured regularly, including a specific check at week 48
Regular health assessments will monitor for any heart-related events
4Health monitoring
Your heart health will be closely monitored for events such as:
– Heart attacks
– Need for urgent heart procedures
– Stroke
– Any heart-related complications
5Study completion
The study will end in February 2031
Final health assessments will be conducted
Your doctor will discuss follow-up care options with you
Who Can Join the Study?
Must be able to provide written informed consent (agreement to participate) before any study procedures begin
Must be 50 years or older at the time of signing the screening consent form
Must have a lipoprotein(a) level of 200 nmol/L or higher (a type of blood fat that will be measured during screening)
Must be on stable lipid-lowering therapy (medications that help control blood fats) for at least 4 weeks before screening
Must meet at least one of these conditions:
Have multiple risk factors for heart and blood vessel disease
OR have a history of atherosclerosis (buildup of plaque in arteries)
Both men and women can participate in the study
Who Cannot Join the Study?
History of heart attack (myocardial infarction) or coronary revascularization (heart procedure to restore blood flow)
Currently taking medications that significantly affect blood lipids (fat-like substances in blood)
Severe kidney disease or currently on dialysis (blood filtering treatment)
Uncontrolled high blood pressure (blood pressure consistently above 160/100)
History of bleeding disorders or significant bleeding events in the past 6 months
Active liver disease or abnormal liver function tests
Current participation in other clinical trials or within past 30 days
Known allergic reactions to similar medications
Pregnant women or those planning pregnancy during the study period
History of substance abuse within the past year
Any condition that, in the opinion of study doctors, would make participation unsafe
Unable to provide informed consent or follow study procedures
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Hungary
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Czechia
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Huelva
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Austria
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France
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Want to learn more about this study or check if you can participate? Contact us.
Trial status
Country
Status
Recruitment Start
Austria
Not yet recruiting
30.09.2025
Belgium
Not yet recruiting
30.09.2025
Bulgaria
Not yet recruiting
30.09.2025
Czechia
Not yet recruiting
30.09.2025
Denmark
Not yet recruiting
30.09.2025
France
Not yet recruiting
30.09.2025
Germany
Not yet recruiting
30.09.2025
Greece
Not yet recruiting
30.09.2025
Hungary
Not yet recruiting
30.09.2025
Ireland
Not yet recruiting
30.09.2025
Italy
Not yet recruiting
30.09.2025
Poland
Not yet recruiting
30.09.2025
Portugal
Not yet recruiting
30.09.2025
Romania
Not yet recruiting
30.09.2025
Slovakia
Not yet recruiting
30.09.2025
Spain
Not yet recruiting
30.09.2025
The Netherlands
Not yet recruiting
30.09.2025
Trial locations
Olpasiran is an investigational medication designed to reduce levels of lipoprotein(a), also known as Lp(a), in the blood. This medication is being studied to prevent first major cardiovascular events in people who have high levels of lipoprotein(a). Olpasiran works by targeting and reducing the production of lipoprotein(a), which is a type of fat-protein particle that can contribute to heart disease when present in elevated amounts.
The trial also includes a placebo, which is not an active medication but is used as a comparison to evaluate the effectiveness of olpasiran.
Coronary Heart Disease – A condition where the heart’s blood vessels become narrowed or blocked by fatty deposits called plaques. This process develops gradually over many years as cholesterol and other substances build up on the artery walls. The reduced blood flow can cause chest pain and shortness of breath during physical activity.
Myocardial Infarction – Also known as a heart attack, it occurs when blood flow to a part of the heart muscle becomes blocked. The blockage is usually caused by a buildup of fatty deposits in the coronary arteries that suddenly ruptures and forms a clot. This leads to damage or death of the affected heart muscle tissue.
Ischemic Stroke – A condition that occurs when blood flow to the brain is blocked by a clot in a blood vessel. The blockage prevents brain cells from receiving oxygen and nutrients they need. This type of stroke develops suddenly and affects specific areas of the brain depending on which blood vessel is blocked.
Cardiovascular Disease – A broad term for conditions affecting the heart and blood vessels throughout the body. It develops when arteries become stiff and narrow, making it harder for blood to flow freely. The condition typically progresses slowly over many years and can affect different parts of the circulatory system.
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