Skip to main content
OpenTrials
Completed

NCT Number: NCT03887520

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiovascular Disease and Lipoprotein(a) Cardiovascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Novartis Investigative Site, CABA, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Patients currently enrolled in clinical studies with investigational drugs

Treatment and study plan

Blood draw for Lp(a)

Diagnostic Test

Collect sample for Lipoprotein(a) testing

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

Primary outcomes

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

    Time frame: At screening

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

Secondary outcomes

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

    Time frame: At screening

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

  2. Lp(a) values by region and country

    Time frame: At screening

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

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

    Time frame: At screening

    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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Multi-center Cross-sectional Epidemiological Study to Characterize the Prevalence and Distribution of Lipoprotein(a) Levels Among Patients With Established Cardiovascular Disease

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Mar 25, 2019
Registry last updated
Jan 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.