Study of Lipoprotein(a) Levels in Patients With a History of ASCVD
Research type
Research Study
Full title
A Multicenter, Cross-sectional Study to Characterize the Distribution of Lipoprotein(a)Levels Among Patients With Documented History of Atherosclerotic Cardiovascular Disease (ASCVD)
IRAS ID
310751
Contact name
Azfar Zaman
Contact email
Sponsor organisation
Amgen
Clinicaltrials.gov Identifier
www.amgentrials.com/s/20210057, Summary of Results Website
Duration of Study in the UK
0 years, 9 months, 3 days
Research summary
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) is an LDL created in the liver, and the amount an individual produces is mostly determined by their genetics. High levels of Lp(a) in the blood, have been previously linked to an increased risk in Atherosclerotic Cardiovascular Disease (ASCVD) and ASCVD events, such as heart attacks or aortic stenosis (a narrowing of the aortic valve opening). For patients who have known ASCVD, many do not undergo routine blood testing of their Lp(a) levels. Until more recently, the role of Lp(a) was not well understood and therefore, it was not routinely tested for in clinical practice. Therefore the known levels of Lp(a) levels within patients who have known ASCVD, especially within each country/region, is limited.
The aim of this research is to collect data on Lp(a) in patients with known ASCVD, who have a documented history of Myocardial Infarction (heart attacks) or have undergone a Percutaneous Coronary Intervention (a non-surgical procedure used to treat narrowing of the coronary arteries of the heart). This will help the Sponsor to better understand the risk of elevated Lp(a) in patients with ASCVD.
Summary of Results
1. Study Name
Title of the Study: A Multicentre, Cross-sectional Study to Characterise the Distribution of Lipoprotein(a) Levels Among Patients With Documented History of Atherosclerotic Cardiovascular Disease (ASCVD) Brief Title: A Cross-sectional Study of Lipoprotein(a) Levels in Patients With Documented History of Atherosclerotic Cardiovascular Disease (ASCVD) Protocol Number: 20210057 EU Trial Number: Not available Other identifiers: NCT05378529 Date of this summary: 24 September 2024 What does this summary cover?
This summary shows the main results from one clinical study. The results are only for this study. Other studies may find different results. Researchers and health authorities look at the results of many studies to decide which medicines work best and are safest for patients.
Amgen has committed to make research results available to the public. This summary has been provided as part of that commitment and should not be used for any other purpose. It should not be considered to make a claim for any product or to guide treatment decisions.
2. Who sponsored this study?
Amgen Inc. One Amgen Center Drive Thousand Oaks, CA 91320-1799 USA Phone (United Kingdom): +44 1223 436441 Amgen Inc., the sponsor of the study, makes olpasiran, which is being studied as a possible treatment for people with high levels of lipoprotein(a), which is also known as "Lp(a)". This study was carried out to assess levels of lipoprotein(a) in participants with a known history of atherosclerotic cardiovascular disease (ASCVD). In general, for this study, ASCVD primarily included diseases of the blood vessels supplying the heart with or without possible history of stroke or limb arterial disease. Olpasiran and other Amgen medicines or devices were not tested in this study.
Amgen would like to thank everyone who participated in this study, and feels it is important to share the study results.
3. General information about the clinical study Where and when was the study done?
• This study took place at 734 study centers in 36 countries.
• The study began in April 2022 and ended in December 2023.
• The study was completed as plannedWhy was the study done?
• Atherosclerotic cardiovascular disease is a serious disease in which fat, cholesterol and other parts of the blood are deposited on the walls of the arteries (blood vessels). Severe buildup of these deposits (plaques) can block blood flow and increase the risk of serious cardiovascular events such as heart attacks, strokes or other blood vessel diseases. Lipoprotein(a) is a sticky particle that also carries cholesterol in the blood. High levels of lipoprotein(a) can increase the chance of plaques or blood clots in the arteries.
• This was a phase 0 cross-sectional study, which means that no medicines were tested. It looked at data from a group of people at a single point in time. The main purpose of this study was to assess lipoprotein(a) levels of 90 mg/dL (or 200 nmol/L) or more in people with a known history of ASCVD, particularly heart disease.
• The researchers used the lipoprotein(a) values shown in the participant’s medical records. In cases where lipoprotein(a) values were not available, a blood sample was taken from the participants.
4. Who was included in this study?
Who took part in the study?
• Participants were examined by a study doctor and chosen to be in the study if they were 18 years old or older and had a medical history of ASCVD, demonstrated by either a heart attack and/or a surgical procedure used to treat the narrowing of the heart arteries, with high-risk features such as the following:
o age above 65 years
o diabetes
o history of stroke or limb arterial disease
o moderate post-procedural arterial plaques, or significant plaques in multiple heart arteries requiring a procedure
• This study examined 39,454 participants who ranged in age from 19 to 93 years.
This study took place at 734 centers across the following countries:
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, Italy, Japan, Lithuania, Mexico, Netherlands, Norway, Poland, Portugal, Republic of Korea, Romania, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States.
5. Which medicines were studied?
No medicines were administered or studied in this study.
6. What were the side effects?
All medicines can cause side effects or unwanted medical problems that may happen when you take a medicine. However, this study did not test any medicine, and therefore, no side effects were reported.
7. What were the overall results of the study?
How many participants with a known history of heart attack and/or surgical procedure used to treat narrowing of the arteries (with high-risk features) had lipoprotein(a) levels of 90 mg/dL (or 200 nmol/L) or more?
• Out of the 39,454 participants examined in this study, the researchers identified 10,019 participants (25%, or about 25 out of 100) who had lipoprotein(a) values of 90 mg/dL (or 200 nmol/L) or more.
• 5,372 participants had known values of lipoprotein(a) at the start of the study, and of these, 5,312 participants (99% or 99 out of 100) had lipoprotein(a) values of 90 mg/dL (or 200 nmol/L) or more.
More results may be available on the websites listed at the end of this summary.
8. How has this study helped the participants and researchers?
What else is it important to know about these results?
These results are only for this clinical study, which looked at a sample of 39,454 people with a history of ASCVD. Other studies may find different results. This research may help future participants and families by helping doctors understand more about the disease being studied.
9. Are there plans for further studies in the future?
If more clinical studies are done, they may be listed on public websites, such as those below. On the website below, search for the study medicine name 'olpasiran' for ASCVD or for elevated lipoprotein(a).
10. Where can I find more information about this study?
To find out more about this study, visit this website:
• https://gbr01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.clinicaltrials.gov%2F&data=05%7C02%7Cderby.rec%40hra.nhs.uk%7C116e3822c3df46e4e16808dd1df04b94%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638699640074437468%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=gq12LItpVSbZw0uvDCe%2F92AKtMsbYKLJUHC9SM0cIEQ%3D&reserved=0. Use the study identifier NCT05378529.
If you participated in the study and have questions about the study results, the doctor or staff at your study site may be able to answer them.REC name
East Midlands - Derby Research Ethics Committee
REC reference
22/EM/0102
Date of REC Opinion
10 May 2022
REC opinion
Further Information Favourable Opinion