A study to evaluate the effect of olpasiran on major cardiovascular events in patients with atherosclerotic cardiovascular disease and high levels of lipoprotein(a)
This study investigates the effects of olpasiran in individuals diagnosed with atherosclerotic cardiovascular disease, a condition where plaque builds up in the arteries, and elevated lipoprotein (a), which is a specific type of fatty protein found in the blood. The purpose of the study is to compare the impact of the study drug against a placebo on the risk of major heart-related issues. These issues include coronary heart disease death, myocardial infarction, or the need for urgent coronary revascularization, which is a procedure used to restore blood flow to the heart.
Participants will be assigned to receive either olpasiran or a placebo through a subcutaneous injection, which means the medication is delivered into the fatty tissue just under the skin. During the study, researchers will monitor for various health events such as ischemic stroke, which is a blockage of blood flow to the brain, and cardiovascular death. The study will also track changes in the levels of lipoprotein (a) in the blood over time to see how the treatment affects this substance.
Who Can Join the Study?
You must provide informed consent, which means you agree to participate in the study after being given all the necessary information.
You must be between 18 and 85 years old at the time you sign the consent form.
Your blood test must show high levels of Lp(a) (lipoprotein a), which is a specific type of fatty substance in your blood, with a level of 200 nmol/L or higher.
You must have been taking a stable and effective dose of lipid-lowering therapy (medicine used to lower cholesterol or fats in the blood) for at least 2 weeks before your testing.
You must have a history of atherosclerotic cardiovascular disease (ASCVD), which is a condition where the arteries that carry blood to the heart become narrowed or blocked by buildup.
Your history must include either a myocardial infarction (commonly known as a heart attack) or coronary revascularization (a procedure used to improve blood flow to the heart, such as percutaneous coronary intervention, which is a way to open blocked heart arteries using a small tube and a balloon or stent).
Who Cannot Join the Study?
You have severe renal dysfunction, which means your kidneys are not working well enough. This is measured by a test called eGFR, which checks how well your kidneys filter waste from your blood.
You have high levels of certain liver enzymes, specifically AST or ALT, or high levels of total bilirubin. These are tests used to check for liver health or damage.
You have a history of hemorrhagic stroke, which is a type of stroke caused by bleeding inside the brain.
You have a history of a major bleeding disorder, such as hemophilia or von Willebrand disease, which are conditions that prevent your blood from clotting properly.
You have had a major cardiovascular event within the last 4 weeks. This includes things like a myocardial infarction (heart attack), unstable angina (chest pain caused by reduced blood flow), PCI (a procedure to open clogged heart arteries), coronary artery bypass graft (surgery to improve blood flow to the heart), or a stroke.
You have a planned cardiac surgery or arterial revascularization, which are medical procedures intended to improve blood flow through your arteries or heart.
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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 recruiting
17.03.2023
Belgium
Not recruiting
17.03.2023
Bulgaria
Not recruiting
17.03.2023
Czechia
Not recruiting
17.03.2023
Denmark
Not recruiting
17.03.2023
Estonia
Not recruiting
17.03.2023
Finland
Not recruiting
17.03.2023
France
Not recruiting
17.03.2023
Germany
Not recruiting
17.03.2023
Greece
Not recruiting
17.03.2023
Hungary
Not recruiting
17.03.2023
Iceland
Not recruiting
17.03.2023
Italy
Not recruiting
17.03.2023
Lithuania
Not recruiting
17.03.2023
Norway
Not recruiting
17.03.2023
Poland
Not recruiting
17.03.2023
Portugal
Not recruiting
17.03.2023
Romania
Not recruiting
17.03.2023
Slovakia
Not recruiting
17.03.2023
Spain
Not recruiting
17.03.2023
Sweden
Not recruiting
17.03.2023
The Netherlands
Not recruiting
17.03.2023
Trial locations
Olpasiran is an injectable medication used to help lower the levels of a specific type of fat in the blood called lipoprotein (a). In this study, it is being tested to see if it can reduce the risk of serious heart problems, such as heart attacks or the need for urgent heart procedures, in people who already have heart disease.
Atherosclerotic cardiovascular disease – This condition occurs when fatty deposits, called plaques, build up inside the arteries. These plaques can cause the arteries to narrow and harden over time. As the buildup increases, it restricts the flow of oxygen-rich blood to various parts of the body. This process can lead to blockages in the vessels that supply the heart or the brain. Eventually, the reduced blood flow may cause significant damage to these organs.
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