OCEAN(a)-PreEvent - Clinical Trial
What is the Purpose of this Study?
In this study, people will visit the clinic about every twelve weeks for checkups, lab tests, and other health exams. At each visit, they will receive a shot under the skin. The shot will either contain the study medicine, called olpasiran, or a placebo, which is a shot with no medicine in it. Participants are placed into one of these two groups by chance, like flipping a coin, and neither the doctor nor the participant will know which one they are getting.
The study will last for several years. During this time, the team will check blood tests, look at heart health, and watch for any side effects. The main goal is to learn if olpasiran can safely lower Lp(a) levels and help prevent serious heart problems in the future.
This study is for people who have a high amount of a fat in their blood called lipoprotein(a), or Lp(a). When Lp(a) is too high, it can build up in the arteries and make heart disease more likely. To join the study, a person must have Lp(a) levels of at least 200 nmol/L and must also have health problems that raise their chance of heart trouble. These problems can include high blood pressure, diabetes, smoking, kidney disease, being 65 or older, or having family members who had heart disease at a young age. A person can also join if tests show plaque or narrowing in their arteries.
People cannot take part if they already had a heart attack, stroke, or a procedure to fix blocked arteries. They also cannot join if they have very serious health issues like bad kidney or liver disease, very high blood pressure that cannot be controlled, or very high triglycerides. The study is for people who have not yet had a major heart problem and want to help researchers learn if lowering Lp(a) can help protect their heart.
Who Can Participate in the Study?
People can join this study if they are at least 50 years old and have a high amount of lipoprotein(a), also called Lp(a), in their blood. Their Lp(a) level must be 200 nmol/L or higher. They must also have health conditions that make heart disease more likely, such as high blood pressure, diabetes, smoking, kidney disease, or a family history of early heart problems. They can also join if tests show plaque building up in their arteries. They must have been taking the same cholesterol‑lowering medicine for at least four weeks before joining and must never have had a major heart problem like a heart attack, stroke, or a procedure to open blocked arteries.
What is Involved?
This study wants to find out if a medicine called olpasiran can lower a type of fat in the blood called lipoprotein(a), or Lp(a). When Lp(a) is too high, it can increase a person’s chance of having heart disease. The goal of the study is to see if lowering Lp(a) can help stop someone from having their first major heart problem, such as a heart attack. By doing this research, doctors hope to learn better ways to protect people with high Lp(a) from heart disease in the future.
Study Details
