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