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

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 30, 2021

Interventions

  • Diagnostic Test: Blood draw for Lp(a)
    • Collect sample for Lipoprotein(a) testing

Arms, Groups and Cohorts

  • Other: Cardiovascular disease
    • Patients with established Cardiovascular disease

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • 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
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Novartis Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Novartis Pharmaceuticals, 1-888-669-6682, novartis.email@novartis.com

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