CClinicalTrials.gg
CompletedNCT03887520Updated Jan 28, 2022

Lipoprotein(a) in Patients With Cardiovascular Disease (CVD)

An interventional study of Blood draw for Lp(a) in Cardiovascular Disease and Lipoprotein(a), sponsored by Novartis Pharmaceuticals. Completed at 904 sites in 49 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-01-28.

Sponsored by Novartis Pharmaceuticals · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Nov 2018, registered Mar 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
49,001
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The study is conducted to improve knowledge about the epidemiology of Lipoprotein(a) in patients with established cardiovascular disease (CVD).

02

Conditions studied

  • Cardiovascular Disease and Lipoprotein(a)

Keywords

  • CVD, Lipoprotein (a),
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 49,001 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Signed informed consent
  • Established CVD defined as one of the following:

    • History of a myocardial infarction (MI) ≥3 months and ≤10 years before the study visit
    • History of ischemic stroke ≥ 3 months and ≤ 10 years before the study visit
    • Symptomatic PAD (intermitted claudication with ankle-brachial index ≤0.90 and/or lower limb amputation or re-vascularization due to lower limb ischemia

Exclusion criteria

Exclusion Criteria:

  • Patients currently enrolled in clinical studies with investigational drugs
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
49,001 participants (actual)

Study arms

  • Other
    Cardiovascular disease

    Patients with established Cardiovascular disease

    Diagnostic Test: Blood draw for Lp(a)

Interventions

  • Diagnostic testBlood draw for Lp(a)

    Collect sample for Lipoprotein(a) testing

    Also known as: In case retrospective laboratory data are not available, blood sampling will be performed to analyze Lp(a)

06

What researchers measure

Primary outcomes

  1. Percentage of patients with normal and elevated Lipoprotein(a) (Lp(a)) levels in patients with established Cardiovascular Disease (CVD)

    Prevalence of normal and elevated Lp(a) levels in patients with established CVD

    Time frame: At screening

Secondary outcomes

  1. Lipoprotein(a) (Lp(a)) values

    Evaluate the median and other relevant statistics describing the distribution of Lp(a) within the normal range and elevated Lp(a) levels

    Time frame: At screening

  2. Lp(a) values by region and country

    Evaluate the median and other relevant statistics describing the distribution of Lp(a) by region and country

    Time frame: At screening

  3. Low-density lipoprotein cholesterol (LDL(C)) values (corrected and uncorrected)

    Evaluate the median and other relevant statistics describing the distribution of LDL-C (corrected and uncorrected) within the normal range and with elevated Lp(a) levels

    Time frame: At screening

07

Study locations

904 sites
  • Novartis Investigative Site
    Andalusia, Alabama 36420, United States
  • Novartis Investigative Site
    Birmingham, Alabama 35243, United States
  • Novartis Investigative Site
    Huntsville, Alabama 35801, United States
  • Novartis Investigative Site
    Mobile, Alabama 36608, United States
  • Novartis Investigative Site
    Cottonwood, Arizona 86326, United States
  • Novartis Investigative Site
    Mesa, Arizona 85206, United States
  • Novartis Investigative Site
    Surprise, Arizona 85374, United States
  • Novartis Investigative Site
    Tucson, Arizona 85745, United States
  • Novartis Investigative Site
    Little Rock, Arkansas 72204, United States
  • Novartis Investigative Site
    Beverly Hills, California 90211, United States
  • Novartis Investigative Site
    Concord, California 94520, United States
  • Novartis Investigative Site
    Covina, California 91723, United States
  • Novartis Investigative Site
    Fresno, California 93720, United States
  • Novartis Investigative Site
    Huntington Beach, California 92648, United States
  • Novartis Investigative Site
    Long Beach, California 90806, United States
  • Novartis Investigative Site
    Los Angeles, California 90033, United States
  • Novartis Investigative Site
    Los Angeles, California 90073, United States
  • Novartis Investigative Site
    Northridge, California 91325, United States
  • Novartis Investigative Site
    Orangevale, California 95662, United States
  • Novartis Investigative Site
    Orange, California 92868, United States
  • Novartis Investigative Site
    San Diego, California 92103, United States
  • Novartis Investigative Site
    San Francisco, California 94143, United States
  • Novartis Investigative Site
    Santa Ana, California 92704, United States
  • Novartis Investigative Site
    Stanford, California 94305, United States
  • Novartis Investigative Site
    Stockton, California 95204, United States
  • Novartis Investigative Site
    Torrance, California 90502, United States
  • Novartis Investigative Site
    West Hills, California 91307, United States
  • Novartis Investigative Site
    Aurora, Colorado 80045, United States
  • Novartis Investigative Site
    Bridgeport, Connecticut 06610, United States
  • Novartis Investigative Site
    Hartford, Connecticut 06102-5037, United States
  • Novartis Investigative Site
    Waterbury, Connecticut 06708, United States
  • Novartis Investigative Site
    Boca Raton, Florida 33434, United States
  • Novartis Investigative Site
    Bradenton, Florida 34209, United States
  • Novartis Investigative Site
    Brandon, Florida 33511, United States
  • Novartis Investigative Site
    Hollywood, Florida 33312, United States
  • Novartis Investigative Site
    Jacksonville, Florida 32205, United States
  • Novartis Investigative Site
    Jacksonville, Florida 32216, United States
  • Novartis Investigative Site
    Jacksonville, Florida 32223, United States
  • Novartis Investigative Site
    Miami, Florida 33133, United States
  • Novartis Investigative Site
    Miami, Florida 33176, United States
  • Novartis Investigative Site
    Naples, Florida 34102, United States
  • Novartis Investigative Site
    Port Charlotte, Florida 33952, United States
  • Novartis Investigative Site
    Port Orange, Florida 32127, United States
  • Novartis Investigative Site
    Saint Augustine, Florida 32086, United States
  • Novartis Investigative Site
    Tampa, Florida 33612, United States
  • Novartis Investigative Site
    Wellington, Florida 33449, United States
  • Novartis Investigative Site
    Atlanta, Georgia 30084, United States
  • Novartis Investigative Site
    Atlanta, Georgia 30309, United States
  • Novartis Investigative Site
    Atlanta, Georgia 30322, United States
  • Novartis Investigative Site
    Dunwoody, Georgia 30338, United States
  • Novartis Investigative Site
    Thomasville, Georgia 31792, United States
  • Novartis Investigative Site
    Chicago, Illinois 60612, United States
  • Novartis Investigative Site
    Lombard, Illinois 60148, United States
  • Novartis Investigative Site
    Park Ridge, Illinois 60068, United States
  • Novartis Investigative Site
    Skokie, Illinois 60077, United States
  • Novartis Investigative Site
    Indianapolis, Indiana 46202 4800, United States
  • Novartis Investigative Site
    Indianapolis, Indiana 46260, United States
  • Novartis Investigative Site
    Iowa City, Iowa 52242, United States
  • Novartis Investigative Site
    Kansas City, Kansas 66160, United States
  • Novartis Investigative Site
    Topeka, Kansas 66606, United States
  • Novartis Investigative Site
    Louisville, Kentucky 40213, United States
  • Novartis Investigative Site
    Alexandria, Louisiana 71301, United States
  • Novartis Investigative Site
    Baton Rouge, Louisiana 70808, United States
  • Novartis Investigative Site
    Covington, Louisiana 70433, United States
  • Novartis Investigative Site
    Hammond, Louisiana 70403, United States
  • Novartis Investigative Site
    Houma, Louisiana 70360, United States
  • Novartis Investigative Site
    Lafayette, Louisiana 70501, United States
  • Novartis Investigative Site
    Metairie, Louisiana 70006, United States
  • Novartis Investigative Site
    New Orleans, Louisiana 70112, United States
  • Novartis Investigative Site
    New Orleans, Louisiana 70115, United States
  • Novartis Investigative Site
    Opelousas, Louisiana 70570, United States
  • Novartis Investigative Site
    Shreveport, Louisiana 71101, United States
  • Novartis Investigative Site
    Slidell, Louisiana 70458, United States
  • Novartis Investigative Site
    Zachary, Louisiana 70791, United States
  • Novartis Investigative Site
    Scarborough, Maine 04074, United States
  • Novartis Investigative Site
    Baltimore, Maryland 21201, United States
  • Novartis Investigative Site
    Baltimore, Maryland 21209, United States
  • Novartis Investigative Site
    Baltimore, Maryland 21287, United States
  • Novartis Investigative Site
    Columbia, Maryland 21044, United States
  • Novartis Investigative Site
    Fort Washington, Maryland 20744, United States
  • Novartis Investigative Site
    Rockville, Maryland 20850, United States
  • Novartis Investigative Site
    Boston, Massachusetts 02114-2696, United States
  • Novartis Investigative Site
    Boston, Massachusetts 02115, United States
  • Novartis Investigative Site
    Bingham Farms, Michigan 48025, United States
  • Novartis Investigative Site
    Detroit, Michigan 48201, United States
  • Novartis Investigative Site
    Detroit, Michigan 48202, United States
  • Novartis Investigative Site
    Flint, Michigan 48504, United States
  • Novartis Investigative Site
    Grand Blanc, Michigan 48439, United States
  • Novartis Investigative Site
    Kalamazoo, Michigan 49008, United States
  • Novartis Investigative Site
    Midland, Michigan 48640, United States
  • Novartis Investigative Site
    Petoskey, Michigan 49770, United States
  • Novartis Investigative Site
    Saginaw, Michigan 48601, United States
  • Novartis Investigative Site
    Wyoming, Michigan 49519, United States
  • Novartis Investigative Site
    Minneapolis, Minnesota 55407, United States
  • Novartis Investigative Site
    Minneapolis, Minnesota 55455, United States
  • Novartis Investigative Site
    Saint Paul, Minnesota 55102, United States
  • Novartis Investigative Site
    Belzoni, Mississippi 39038, United States
  • Novartis Investigative Site
    Jackson, Mississippi 39209, United States
  • Novartis Investigative Site
    Southaven, Mississippi 38671, United States
  • Novartis Investigative Site
    Yazoo City, Mississippi 39194, United States

Showing the first 100 of 904 sites across 49 countries.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03887520
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Mar 25, 2019
Start date
Nov 27, 2018
Primary completion
Jul 30, 2021
Completion
Jul 30, 2021
Last update
Jan 28, 2022

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals

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 Jan 2022. You cannot join it, but the record below documents what was studied.

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