Active not recruitingPHASE3INTERVENTIONAL

Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction (OCEAN(a)) - Outcomes Trial

This research study, called OCEAN(a), is looking into a new medicine named olpasiran. It's designed for people who already have heart disease and high levels of a particular type of fat in their blood, known as Lipoprotein(a), or Lp(a). Doctors believe high Lp(a) might increase the risk of heart problems. The main goal of this study is to compare olpasiran with a dummy medicine (placebo). Researchers want to see if taking olpasiran can reduce the chances of serious heart events like heart attacks, urgent heart operations, or death from heart disease. This is a large-scale study (Phase 3), which means it's one of the final steps before a medicine might become widely available.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Amgen

Enrolment target

7,297

Start

14 Dec 2022

Estimated completion

31 Mar 2028

Atherosclerotic Cardiovascular Disease

What is this study about?

You might be reading this because you or someone you know has been affected by heart disease. This study is focusing on a specific type of fat in your blood called Lipoprotein(a), or Lp(a). We know that having high levels of Lp(a) can sometimes make heart problems more likely for certain people. Doctors are always looking for new ways to protect hearts, and this study is testing a new medicine, olpasiran, that might help to lower these high Lp(a) levels.

The main aim of the OCEAN(a) study is to find out if olpasiran can truly make a difference. We want to see if it can help reduce the risk of serious heart-related events like having another heart attack, needing emergency heart surgery, or even dying from heart disease. We'll be comparing olpasiran against a 'placebo', which is a dummy medicine that looks just like olpasiran but contains no active drug. This helps us to see if any improvements are actually due to the new medicine or other factors.

This is a 'Phase 3' study, meaning it's a large and important step in checking if a new medicine is safe and effective enough for people to use more widely. By taking part, you could be helping doctors learn more about how to manage heart disease and potentially develop new treatments for the future.

Key takeaways

This study is testing a new medicine, olpasiran, for people with heart disease.
It focuses on lowering high levels of a blood fat called Lipoprotein(a) (Lp(a)).
The main goal is to see if olpasiran can reduce the risk of heart attacks and other heart problems.
Participants will receive either olpasiran or a dummy medicine (placebo).
The study involves regular clinic visits for monitoring and blood tests.
Taking part could help advance understanding and treatment of heart disease.

Who may be eligible?

To join this study, you need to be an adult between 18 and 85 years old. You must have had heart disease in the past, such as a heart attack or a procedure to unblock arteries in your heart. We also need to check your blood to see if you have high levels of a specific fat called Lipoprotein(a), or Lp(a).

There are some reasons why you might not be able to join. For example, if you have severe kidney or liver problems, certain bleeding disorders, or have had a specific type of stroke in the past, this study might not be right for you. Also, if you're planning to have major heart surgery soon, or are currently undergoing a special blood filtering treatment called lipoprotein apheresis, you wouldn't be able to participate.

Your study doctor will go through all the detailed requirements with you to make sure this study is a safe and suitable option. It's important to be open about your full medical history so they can make the best decision for your health.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 85 years old?
Have you been diagnosed with heart disease (like a past heart attack)?
Have you had a blood test showing high Lipoprotein(a) (Lp(a)) levels?
Do you have severe kidney or liver problems? (If yes, you might not be eligible)
Are you currently having or planning major heart surgery soon? (If yes, you might not be eligible)

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be assigned to either receive the new medicine, olpasiran, or a dummy medicine (placebo). You wouldn't know which one you're receiving, and neither would your study doctor. You'd have regular visits to the clinic, where the study team would monitor your health closely, take blood samples, and check how you're feeling. They would also provide you with the study medication. The total duration of the study hasn't been specified in detail but generally, these types of studies involve follow-up for several years until enough health events have occurred to evaluate the medicine's effect.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. The potential benefit is that olpasiran might reduce your risk of future heart problems, but we don't know for sure yet, which is why we are doing the study. There might be side effects from the medicine, or discomfort from blood tests and other procedures. All study treatments have the potential for side effects, which will be carefully monitored. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (737)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Ascension Saint Vincents Birmingham
Verified postcode
Birmingham, United States
Grandview Medical Center Affinity Cardiovascular Specialists, LLC
Verified postcode
Birmingham, United States
Heart Center Research LLC
Verified postcode
Huntsville, United States
Mobile Heart Specialists PC
Verified postcode
Mobile, United States
Alaska Cardiovascular Research Foundation
Verified postcode
Anchorage, United States
Elite Clinical Studies LLC
Verified postcode
Phoenix, United States
HonorHealth Research and Innovation Institute
Verified postcode
Scottsdale, United States
National Heart Institute
Verified postcode
Beverly Hills, United States
Vitality Clinical Research
Verified postcode
Beverly Hills, United States
University of California San Diego
Verified postcode
La Jolla, United States
VA Greater Los Angeles Healthcare System
Verified postcode
Los Angeles, United States
University of California Irvine
Verified postcode
Orange, United States

Common questions

What is Lipoprotein(a) and why is it important?

Lipoprotein(a), or Lp(a), is a type of fat in your blood. High levels can sometimes be linked to a higher risk of heart disease, even if your other cholesterol levels are normal.

What is a 'placebo'?

A placebo is a dummy treatment. It looks exactly like the real medicine but doesn't contain any active drug. We use it to compare against the new medicine to see if it's truly effective.

Will I know if I'm getting the real medicine or the placebo?

No, this is a 'blinded' study. Neither you nor your study doctor will know whether you are receiving olpasiran or the placebo. This helps make the study results fair and accurate.

How long will I need to be in the study?

The information provided doesn't specify the exact duration, but studies like this usually involve follow-up for several years to track health outcomes over time.

What if my health changes during the study?

Your health will be closely monitored throughout the study. If anything changes, or if you experience any new symptoms, it's important to tell the study team immediately.