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Trial record 1 of 2 for:    20210057
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A Cross-sectional Study of Lipoprotein(a) Levels in Patients With Documented History of Atherosclerotic Cardiovascular Disease (ASCVD)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05378529
Recruitment Status : Recruiting
First Posted : May 18, 2022
Last Update Posted : June 1, 2023
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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Brief Summary:

The purpose of this study is to characterize the distribution of lipoprotein(a) (Lp(a)) levels among participants with a history of ASCVD as defined by their medical history and is 2-fold:

  • Evaluate the distribution of Lp(a) value in the overall participants with documented history of ASCVD
  • Evaluate the distribution of Lp(a) value in participants with documented history of ASCVD by demographics and regions

Condition or disease Intervention/treatment Phase
Atherosclerotic Cardiovascular Disease Other: Lp(a) Screening Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Multicenter, Cross-sectional Study to Characterize the Distribution of Lipoprotein(a) Levels Among Patients With Documented History of Atherosclerotic Cardiovascular Disease
Actual Study Start Date : April 19, 2022
Estimated Primary Completion Date : January 5, 2024
Estimated Study Completion Date : January 5, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

Arms and Interventions
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Arm Intervention/treatment
Participants with history of ASCVD
Participants with history of ASCVD with known or unknown Lp(a) values.
 Other: Lp(a) Screening
Participants will provide demographic information and have a blood draw for Lp(a) levels if they are unknown.


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with elevated Lp(a) with documented history of ASCVD [ Time Frame: Up to approximately 2 weeks ]

Secondary Outcome Measures :
  1. Lp(a) Levels [ Time Frame: Up to approximately 2 weeks ]
    Blood sampling will be performed in cases where Lp(a) values are not available at enrollment. In cases where Lp(a) values are available, data will be collected retrospectively.

  2. Lp(a) Levels stratified by demographics and region [ Time Frame: Up to approximately 2 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent
  • History of ASCVD

Exclusion Criteria:

  • Participants known to be currently receiving investigational drug in a clinical study
  • Participants with a diagnosis of end-stage renal disease or requiring dialysis
  • Participants who have received lipoprotein apheresis to reduce Lp(a) within 3 months prior to enrollment
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): NCT05378529


Contacts
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Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
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Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT05378529    
Other Study ID Numbers: 20210057
First Posted: May 18, 2022    Key Record Dates
Last Update Posted: June 1, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
URL: http://www.amgen.com/datasharing

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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 Amgen:
Atherosclerotic Cardiovascular Disease
Lipoprotein(a)
Additional relevant MeSH terms:
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Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases