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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03887520
Recruitment Status : Completed
First Posted : March 25, 2019
Last Update Posted : January 28, 2022
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

Condition or disease Intervention/treatment Phase
Cardiovascular Disease and Lipoprotein(a) Diagnostic Test: Blood draw for Lp(a) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49001 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is a multi-center cross-sectional epidemiological study to estimate the prevalence (%) of patients with elevated Lp(a) in patients with established CVD defined by their medical history. One study visit is planned for data collection. Relevant medical history and laboratory values for LDL-cholesterol (LDL-C) and Lp(a) within a past pre-specified period will be collected retrospectively. In case laboratory data are not available, blood sampling will be performed.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Multi-center Cross-sectional Epidemiological Study to Characterize the Prevalence and Distribution of Lipoprotein(a) Levels Among Patients With Established Cardiovascular Disease
Actual Study Start Date : November 27, 2018
Actual Primary Completion Date : July 30, 2021
Actual Study Completion Date : July 30, 2021

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Arms and Interventions
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Arm Intervention/treatment
Cardiovascular disease
Patients with established Cardiovascular disease
 Diagnostic Test: Blood draw for Lp(a)
Collect sample for Lipoprotein(a) testing
Other Name: In case retrospective laboratory data are not available, blood sampling will be performed to analyze Lp(a)


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03887520


Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03887520    
Other Study ID Numbers: CTQJ230A12001
2018-003786-34 ( EudraCT Number )
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: January 28, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
CVD, Lipoprotein (a),
Additional relevant MeSH terms:
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Cardiovascular Diseases