CClinicalTrials.gg
CompletedNCT05378529Updated Oct 27, 2025

A Cross-sectional Study of Lipoprotein(a) Levels in Patients With Documented History of Atherosclerotic Cardiovascular Disease (ASCVD)

An interventional study of Lp(a) Screening in Atherosclerotic Cardiovascular Disease, sponsored by Amgen. Completed at 735 sites in 36 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-10-27.

Sponsored by Amgen · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
39,480
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study summary

The purpose of this study is to characterize the distribution of lipoprotein(a) (Lp(a)) levels among participants with a history of ASCVD as defined by their medical history and is 2-fold:

  • Evaluate the distribution of Lp(a) value in the overall participants with documented history of ASCVD
  • Evaluate the distribution of Lp(a) value in participants with documented history of ASCVD by demographics and regions
02

Conditions studied

  • Atherosclerotic Cardiovascular Disease

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Keywords

  • Atherosclerotic Cardiovascular Disease
  • Lipoprotein(a)
03

In context

Atherosclerosis

1,567 studies on the registry are indexed under Atherosclerosis; 264 are open to participants now.

This study's enrollment of 39,480 is above the median of 106 across 882 interventional studies indexed under Atherosclerosis.

Browse Atherosclerosis studies →

Lead sponsor

Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.

Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Signed informed consent
  • History of ASCVD

Exclusion criteria

Exclusion Criteria:

  • Participants known to be currently receiving investigational drug in a clinical study
  • Participants with a diagnosis of end-stage renal disease or requiring dialysis
  • Participants who have received lipoprotein apheresis to reduce Lp(a) within 3 months prior to enrollment
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
39,480 participants (actual)

Study arms

  • Other
    Participants with history of ASCVD

    Participants with history of ASCVD with known or unknown Lp(a) values.

    Other: Lp(a) Screening

Interventions

  • OtherLp(a) Screening

    Participants will provide demographic information and have a blood draw for Lp(a) levels if they are unknown.

06

What researchers measure

Primary outcomes

  1. Number of participants with elevated Lp(a) with documented history of ASCVD

    Time frame: Up to approximately 2 weeks

Secondary outcomes

  1. Lp(a) Levels

    Blood sampling will be performed in cases where Lp(a) values are not available at enrollment. In cases where Lp(a) values are available, data will be collected retrospectively.

    Time frame: Up to approximately 2 weeks

  2. Lp(a) Levels stratified by demographics and region

    Time frame: Up to approximately 2 weeks

07

Study locations

735 sites
  • Ascension Saint Vincents Birmingham
    Birmingham, Alabama 35211, United States
  • Grandview Medical Center Affinity Cardiovascular Specialists, LLC
    Birmingham, Alabama 35243, United States
  • Heart Center Research LLC
    Huntsville, Alabama 35801, United States
  • Mobile Heart Specialists PC
    Mobile, Alabama 36608, United States
  • Alaska Cardiovascular Research Foundation
    Anchorage, Alaska 99508, United States
  • Care Access - Mesa
    Mesa, Arizona 85206, United States
  • Elite Clinical Studies LLC
    Phoenix, Arizona 85018, United States
  • Arkansas Cardiology
    Little Rock, Arkansas 72205, United States
  • Care Access - Berkeley
    Berkeley, California 94705, United States
  • National Heart Institute
    Beverly Hills, California 90211, United States
  • NorCal Medical Research, Inc
    Greenbrae, California 94904, United States
  • America Clinical Trials
    Tarzana, California 91356, United States
  • Med Partners, Inc dba Premiere Medical Center, Inc
    Toluca Lake, California 91602, United States
  • UCHealth Memorial Central
    Colorado Springs, Colorado 80909, United States
  • Cardiology Associates of Fairfield County PC
    Stamford, Connecticut 06905, United States
  • Excel Medical Clinical Trials
    Boca Raton, Florida 33434, United States
  • Bay Area Cardiology
    Brandon, Florida 33511, United States
  • Clearwater Cardiovascular Consultants
    Clearwater, Florida 33756, United States
  • Cardiology Associates Research LLC
    Daytona Beach, Florida 32117, United States
  • The Cardiac and Vascular Institute Research
    Gainesville, Florida 32605, United States
  • Elite Cardiac Research Center LLC
    Hialeah, Florida 33013, United States
  • Jellinger and Lerman MD PA dba The Center for Diabetes and Endocrine Care
    Hollywood, Florida 33021, United States
  • East Coast Institute for Research LLC at Northeast Florida Endocrine and Diabetes Research Associate
    Jacksonville, Florida 32204, United States
  • University of Florida
    Jacksonville, Florida 32209, United States
  • East Coast Institute for Research LLC
    Jacksonville, Florida 32216, United States
  • Jacksonville Center for Clinical Research
    Jacksonville, Florida 32216, United States
  • Westside Center for Clinical Research
    Jacksonville, Florida 32216, United States
  • Advanced Research for Health Improvement, LLC
    Naples, Florida 34102, United States
  • Ocala Cardiovascular Research
    Ocala, Florida 34471, United States
  • Millennium Physician Group, LLC dba Charlotte Heart Group Research Center
    Port Charlotte, Florida 33952, United States
  • East Coast Institute for Research, LLC
    Saint Augustine, Florida 32086, United States
  • Saint Johns Center for Clinical Research
    Saint Augustine, Florida 32086, United States
  • Cardiovascular Center of Sarasota
    Sarasota, Florida 34239, United States
  • Care Access - Moss Bluff
    Spring Hill, Florida 34609, United States
  • Care Access - Pebble Beach
    Sun City, Florida 33573, United States
  • Morehouse School of Medicine
    Atlanta, Georgia 30310, United States
  • Northeast Georgia Medical Center Wisteria Building
    Cumming, Georgia 30041, United States
  • Northside Clinical Research
    Johns Creek, Georgia 30024, United States
  • Care Access - Rome
    Rome, Georgia 30161, United States
  • St Lukes Idaho Cardiology Associates
    Meridian, Idaho 83642, United States
  • Northwest Heart Clinical Research LLC
    Arlington Heights, Illinois 60005, United States
  • Midwest Institute for Clinical Research
    Indianapolis, Indiana 46260, United States
  • Cardiovascular Research of Northwest Indiana LLC
    Munster, Indiana 46321, United States
  • Reid Physician Associates
    Richmond, Indiana 47374, United States
  • University of Kansas Medical Center
    Kansas City, Kansas 66160, United States
  • Midwest Heart and Vascular Specialists
    Overland Park, Kansas 66211, United States
  • Saint Elizabeth Covington
    Covington, Kentucky 41011, United States
  • The Research Group of Lexington LLC
    Lexington, Kentucky 40503, United States
  • Louisiana Heart Center
    Hammond, Louisiana 70403, United States
  • Care Access - Lake Charles
    Lake Charles, Louisiana 70601, United States
  • Monroe Research LLC
    Monroe, Louisiana 71201, United States
  • Clinical Trials of America
    West Monroe, Louisiana 71291, United States
  • Northern Light Eastern Maine Medical Center
    Bangor, Maine 04401, United States
  • University of Maryland Medical Center
    Baltimore, Maryland 21201, United States
  • Maryland Cardiovascular Specialists
    Baltimore, Maryland 21229, United States
  • Johns Hopkins University School of Medicine
    Baltimore, Maryland 21287, United States
  • Metropolitan Cardiovascular Consultants LLC
    Beltsville, Maryland 20705, United States
  • TidalHealth Peninsula Regional, Inc
    Salisbury, Maryland 21804, United States
  • Henry Ford Hospital
    Detroit, Michigan 48202, United States
  • Ascension Saint John Hospital
    Detroit, Michigan 48236, United States
  • Healthy Heart Cardiology
    Grand Rapids, Michigan 49546, United States
  • Sparrow Clinical Research Institute
    Lansing, Michigan 48912, United States
  • Arcturus Healthcare, Public Limited Company, Troy Internal Medicine Research Division
    Troy, Michigan 48098, United States
  • Minneapolis Heart Institute Foundation
    Minneapolis, Minnesota 55407, United States
  • Fairview Health Services
    Saint Paul, Minnesota 55102, United States
  • Cardiology Associates Research LLC
    Tupelo, Mississippi 38801, United States
  • Bryan Heart
    Lincoln, Nebraska 68506, United States
  • Palm Research Center Inc
    Las Vegas, Nevada 89128, United States
  • Renown Institute for Heart and Vascular Health
    Reno, Nevada 89502, United States
  • Saint Michaels Medical Center
    Newark, New Jersey 07102, United States
  • New York Presbyterian Medical Group Hudson Valley Cardiology
    Cortlandt Manor, New York 10567, United States
  • WMCHealth Heart and Vascular Institute Kingston Division of Cardiology
    Kingston, New York 12401, United States
  • New York University Langone Health
    New York, New York 10016, United States
  • Northwell Health
    New York, New York 10022, United States
  • Icahn School of Medicine at Mount Sinai
    New York, New York 10029, United States
  • Care Access - Bronx
    The Bronx, New York 10456, United States
  • NY Family Docs
    Woodhaven, New York 11421, United States
  • Asheville Cardiology Associates
    Asheville, North Carolina 28803, United States
  • Novant Health Heart and Vascular Institute
    Charlotte, North Carolina 28204, United States
  • Duke University
    Durham, North Carolina 27710, United States
  • Cone Health
    Greensboro, North Carolina 27401, United States
  • Crossroads Clinical Research Inc
    Mooresville, North Carolina 28117, United States
  • Wake Forest University Health Sciences
    Winston-Salem, North Carolina 27157, United States
  • Lillestol Research LLC
    Fargo, North Dakota 58104, United States
  • University Hospitals Cleveland Medical Center
    Cleveland, Ohio 44106, United States
  • Rama Research LLC
    Marion, Ohio 43302, United States
  • Capital Area Research LLC
    Camp Hill, Pennsylvania 17011, United States
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
  • Prisma Health Midlands Cardiology
    Columbia, South Carolina 29203, United States
  • Piedmont Research Partners
    Fort Mill, South Carolina 29707, United States
  • Monument Health Clinical Research
    Rapid City, South Dakota 57701, United States
  • Tennova Healthcare-Turkey Creek Medical Center
    Knoxville, Tennessee 37934, United States
  • Tennessee Center for Clinical Trials
    Tullahoma, Tennessee 37388, United States
  • Texas Diabetes and Endocrinology
    Austin, Texas 78731, United States
  • Baylor Scott and White Heart and Vascular Hospital-Dallas
    Dallas, Texas 75226, United States
  • Southwest Family Medicine Associates
    Dallas, Texas 75235, United States
  • Care Access - Georgetown
    Georgetown, Texas 78633, United States
  • Baylor College of Medicine
    Houston, Texas 77030, United States
  • Care Access - Katy
    Katy, Texas 77450, United States

Showing the first 100 of 735 sites across 36 countries.

08

References and documents

Individual participant data

Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Supporting information: Study protocol, Sap, Icf, Csr

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05378529
Lead sponsor
Amgen
Responsible party
Sponsor
First posted
May 18, 2022
Start date
Apr 19, 2022
Primary completion
Dec 30, 2023
Completion
Dec 30, 2023
Last update
Oct 27, 2025

Study contacts

MD
study director · Amgen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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