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Getting to an Improved Understanding of Low-Density Lipoprotein Cholesterol and Dyslipidemia Management (GOULD) a Registry of High Cardiovascular Risk Subjects in the United States

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ClinicalTrials.gov Identifier: NCT02993120
Recruitment Status : Active, not recruiting
First Posted : December 15, 2016
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:

This is a multicenter observational cohort study with both retrospective and prospective data collection components in subjects with ASCVD.

The purpose of this study is to better understand cholesterol treatment patterns in the context of a changing landscape in subjects with ASCVD.


Condition or disease
Medical Conditions to be Studied Dyslipidemia ASCVD Management

Detailed Description:

This is a prospective multicenter observational cohort study with retrospective component/chart review of ASCVD subjects that is designed to describe practice patterns of cholesterol management in such subjects in the US. Up to 1 year of retrospective lipid treatment, lipid measurement patterns, and CV data in subjects with ASCVD meeting inclusion/exclusion criteria at enrolled clinical sites will be captured. The retrospective data collection is being performed for the following reasons:

  • Capture relevant factors related to subject's CV risk and pertinent medical history.
  • Capture changes in LLT over time as related to the subject's clinical condition and medical history and adverse events to LLT Eligible subjects will be invited to enroll in chronological order of attending the clinic. The study will enroll 3 subject cohorts with the following rationale:

    1. the first cohort will consist of approximately 500 subjects on PCSK9i at the time of enrollment. The goal is to include a large enough cohort of patients receiving PCSK9i in real world clinical practice; this will allow (for the first time) to better understand the characteristics of those patients whose treatment is escalated to include PCSK9i, the therapeutic effects of PCSK9i outside of the randomized clinical trial settings, and over a prolonged duration of follow up;
    2. the second cohort will enroll approximately 2000 subjects with LDL-C levels greater than or equal to 100 mg/dL. The purpose is to include a large group of patients with established ASCVD and suboptimal LDL control in order to better understand the treatment patterns and rates of CV events in this group;
    3. the third group will enroll approximately 2500 subjects with LDL-C levels between 70 and 99 mg/dL. The purpose is to include a large group of patients with established ASCVD and more optimal control of LDL.
  • To better understand patient characteristics, lipid-lowering treatment management, rates of CV events, and potential opportunities for further LLT optimization in this group. Interactive voice response system will be used to track the number of subjects in each cohort. Once a cohort is filled, no more subjects may be enrolled into it. After the first subject is enrolled and annually thereafter, physicians will fill out a questionnaire on their general use of LLT type and dose and their overall goals of lipid management. The study specific data collection points are aligned with the standard of care physician scheduled visits. Each subject will be followed through a systematic series of medical chart reviews conducted at participating clinical sites. Initial chart reviews will occur at subject enrollment with subsequent scanning of charts occurring at the site every 6 months thereafter. In addition, questionnaires will be administered to subjects every 6 months via a CATI system (wherein an interviewer will ask the subject a series of standard questions) to determine general perceptions and attitudes towards LLT. The order of questions in the questionnaire will be based on subject response. This will facilitate reports of the number of inpatient visits, outpatient visits, outpatient procedures, diagnostic tests, prescription and nonprescription medication use in the prior 6 months. Subjects will be asked to complete questionnaires even if they do not routinely see the enrolling physician or if they have switched providers.

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Study Type : Observational
Actual Enrollment : 5006 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Getting to an Improved Understanding of Low-Density Lipoprotein Cholesterol and Dyslipidemia Management (GOULD) a Registry of High Cardiovascular Risk Subjects in the United States
Actual Study Start Date : December 6, 2016
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : July 30, 2021

Resource links provided by the National Library of Medicine


Group/Cohort
Cohort 1
For the cohort of approximately 500 subjects taking a PCSK9i at baseline: proof consisting of a current prescription for an approved PCSK9i and subject confirmation that they have taken a PCSK9i within 30 days prior to enrollment is necessary.
Cohort 2
• For the cohort of approximately 2000 subjects with LDL-C ≥ 100 mg/dL: confirmation of LDL-C ≥100 mg/dL with no change in LLT for 4 weeks.
Cohort 3
For the cohort of approximately 2500 subjects with LDL-C 70-99 mg/dL: confirmation of LDL-C 70-99 mg/dL with no change in LLT for 4 weeks



Primary Outcome Measures :
  1. Low-density lipoprotein (LDL) treatment patterns [ Time Frame: Through study completion, an average of 3 years ]
    Describe low-density lipoprotein (LDL) treatment patterns over time in subjects with clinical ASCVD


Secondary Outcome Measures :
  1. LDL-C levels and measurement patterns [ Time Frame: Through study completion, an average of 3 years ]
    Describe LDL-C levels and measurement patterns in subjects with clinical ASCVD

  2. Subject Characteristics [ Time Frame: Through study completion, an average of 3 years ]
    Describe subject characteristics

  3. Subject understanding of CV risk [ Time Frame: Through study completion, an average of 3 years ]
    Describe subject understanding of CV risk

  4. Goals of Lipid Management [ Time Frame: Through study completion, an average of 3 years ]
    Describe subject goals of lipid management

  5. Attitudes towards lipid lowering treatment (LLT) [ Time Frame: Through study completion, an average of 3 years ]
    Describe subject attitudes towards lipid lowering treatment (LLT)

  6. Percentage of Subjects Achieving Pre-Specified Levels Low-Density Lipoprotein Cholesterol (LDL-C) Before and After Educational Intervention [ Time Frame: Up to 1 Year ]
    The two levels of LDL-C that will be assessed are < 70 mg/dL and < 55 mg/dL.

  7. Number of Subjects who Experience an Intensification in Lipid-Lowering Therapy Before and After Educational Intervention [ Time Frame: Up to 1 Year ]
  8. Percentage of Subjects on Optimal Medical Therapy Before and After Educational Intervention [ Time Frame: Up to 1 Year ]
  9. Percentage of Physicians Stating a Specific Lipid Treatment Objective Before and After Educational Intervention [ Time Frame: Up to 1 Year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
  • Adults (18-44 years)
  • Adults (45-64 years)
  • Adults (65-74 years)
  • Adults (75 years and older)
  • Sex: Male and Female
Criteria

Inclusion Criteria:

Subject

  • ≥ 18 years of age at signing of informed consent
  • Undergoing treatment with a statin or other non-statin lipid lowering medication
  • at least 1 planned visit in the next 12 months
  • available for follow-up questionnaires
  • established ASCVD defined as meeting at least 1 of the following criteria:

    • coronary artery disease
    • prior history of myocardial infarction
    • coronary or other arterial revascularization
    • ischemic stroke or transient ischemic attack
    • documented peripheral arterial disease secondary to atherosclerosis (eg., aortic aneurysm, ankle brachial index < 0.9, imaging evidence of > 50% stenosis in any peripheral artery, or intermittent claudication)
    • carotid artery stenosis
    • LDL-C levels>69 mg/dL except in subjects assigned to the PCSK9i cohort Cohorts
  • Cohorts are assigned based upon most recent LDL-C level prior to enrollment
  • For the cohort of approximately 500 subjects taking a PCSK9i at baseline: proof consisting of a current prescription for an approved PCSK9i and subject confirmation that they have taken a PCSK9i within 30 days prior to enrollment is necessary
  • For the cohort of approximately 2000 subjects with LDL-C ≥ 100 mg/dL: confirmation of LDL-C ≥ 100 mg/dL with no change in LLT for 4 weeks.
  • For the cohort of approximately 2500 subjects with LDL-C 70-99 mg/dL: confirmation of LDL-C 70-99 mg/dL with no change in LLT for 4 weeks.

Exclusion Criteria:

Subject

  • Unable or unwilling to provide informed consent including but not limited to cognitive or language barriers
  • Current or planned participation in an interventional clinical study involving any investigational medical device or drug treatment at the time of enrollment or in the 6 months prior to enrollment. Subjects who chose to participate in an interventional clinical study of either device or drug treatment after enrollment will be removed from the GOULD study
  • Life expectancy < 12 months
  • Currently pregnant, breast feeding, or planning to become pregnant

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): NCT02993120


Locations
Show Show 118 study locations
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02993120    
Other Study ID Numbers: 20150230
First Posted: December 15, 2016    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
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 (or other new use) 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, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. 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 link below.
URL: https://www.amgen.com/datasharing
Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases