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Trial record 2 of 2 for:    Novartis | Recruiting, Not yet recruiting Studies | lipoprotein

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

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ClinicalTrials.gov Identifier: NCT03887520
Recruitment Status : Recruiting
First Posted : March 25, 2019
Last Update Posted : July 23, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE March 21, 2019
First Posted Date  ICMJE March 25, 2019
Last Update Posted Date July 23, 2020
Actual Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date July 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2019)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lipoprotein(a) in Patients With Cardiovascular Disease (CVD)
Official Title  ICMJE Multi-center Cross-sectional Epidemiological Study to Characterize the Prevalence and Distribution of Lipoprotein(a) Levels Among Patients With Established Cardiovascular Disease
Brief Summary The study is conducted to improve knowledge about the epidemiology of Lipoprotein(a) in patients with established cardiovascular disease (CVD).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Cardiovascular Disease and Lipoprotein(a)
Intervention  ICMJE 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)
Study Arms  ICMJE Cardiovascular disease
Patients with established Cardiovascular disease
Intervention: Diagnostic Test: Blood draw for Lp(a)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 30, 2020)
49995
Original Estimated Enrollment  ICMJE
 (submitted: March 21, 2019)
45000
Estimated Study Completion Date  ICMJE July 30, 2021
Estimated Primary Completion Date July 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   China,   Colombia,   Czechia,   Denmark,   Egypt,   France,   Germany,   Greece,   Guatemala,   Hong Kong,   Hungary,   Iceland,   India,   Israel,   Italy,   Japan,   Korea, Republic of,   Lebanon,   Malaysia,   Mexico,   Netherlands,   Norway,   Peru,   Philippines,   Poland,   Portugal,   Puerto Rico,   Romania,   Russian Federation,   Slovakia,   Slovenia,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Thailand,   Turkey,   United Kingdom,   United States,   Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03887520
Other Study ID Numbers  ICMJE CTQJ230A12001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Novartis
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP