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

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.

Study Overview

• Status: Completed
• Conditions: Dyslipidemia; Medical Conditions to be Studied; 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.

• Study Type: Observational
• Enrollment (Actual): 5006

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Research Site
    • Glendale, Arizona, United States, 85306
      • Research Site
    • Tucson, Arizona, United States, 85712
      • Research Site
    • Tucson, Arizona, United States, 85741
      • Research Site
    • Tucson, Arizona, United States, 85745
      • Research Site
  • California
    • Canoga Park, California, United States, 91303
      • Research Site
    • Cerritos, California, United States, 90703
      • Research Site
    • Los Angeles, California, United States, 90048
      • Research Site
    • Oxnard, California, United States, 93030
      • Research Site
    • Rancho Mirage, California, United States, 92270
      • Research Site
    • Sacramento, California, United States, 95823
      • Research Site
    • Wildomar, California, United States, 92595
      • Research Site
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Research Site
    • Colorado Springs, Colorado, United States, 80906
      • Research Site
    • Lafayette, Colorado, United States, 80026
      • Research Site
  • Connecticut
    • Bloomfield, Connecticut, United States, 06002
      • Research Site
    • Bridgeport, Connecticut, United States, 06610
      • Research Site
    • Hartford, Connecticut, United States, 06102
      • Research Site
    • Stamford, Connecticut, United States, 06905
      • Research Site
  • Florida
    • Boca Raton, Florida, United States, 33434
      • Research Site
    • Brandon, Florida, United States, 33511
      • Research Site
    • Brooksville, Florida, United States, 34601
      • Research Site
    • Daytona Beach, Florida, United States, 32114
      • Research Site
    • Hollywood, Florida, United States, 33021
      • Research Site
    • Homestead, Florida, United States, 33030
      • Research Site
    • Jacksonville, Florida, United States, 32256
      • Research Site
    • Jacksonville, Florida, United States, 32277
      • Research Site
    • Jacksonville Beach, Florida, United States, 32250
      • Research Site
    • Miami, Florida, United States, 33126
      • Research Site
    • Miami, Florida, United States, 33165
      • Research Site
    • Miami, Florida, United States, 33135
      • Research Site
    • Miami, Florida, United States, 33155
      • Research Site
    • Miami, Florida, United States, 33015
      • Research Site
    • Miami, Florida, United States, 33122
      • Research Site
    • Miami Beach, Florida, United States, 33140
      • Research Site
    • Naples, Florida, United States, 34102
      • Research Site
    • Pembroke Pines, Florida, United States, 33028
      • Research Site
    • Pensacola, Florida, United States, 32504
      • Research Site
    • Rockledge, Florida, United States, 32955
      • Research Site
    • Winter Park, Florida, United States, 32792
      • Research Site
  • Georgia
    • Cumming, Georgia, United States, 30041
      • Research Site
    • Smyrna, Georgia, United States, 30082
      • Research Site
  • Idaho
    • Boise, Idaho, United States, 83712
      • Research Site
    • Coeur d'Alene, Idaho, United States, 83814
      • Research Site
    • Meridian, Idaho, United States, 83642
      • Research Site
    • Nampa, Idaho, United States, 83686
      • Research Site
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Research Site
    • Chicago, Illinois, United States, 60637
      • Research Site
    • Chicago, Illinois, United States, 60604
      • Research Site
    • Evanston, Illinois, United States, 60201
      • Research Site
    • Morton, Illinois, United States, 61550
      • Research Site
  • Indiana
    • Evansville, Indiana, United States, 47713
      • Research Site
    • Michigan City, Indiana, United States, 46360
      • Research Site
  • Iowa
    • Davenport, Iowa, United States, 52803
      • Research Site
    • Des Moines, Iowa, United States, 50309
      • Research Site
  • Kentucky
    • Covington, Kentucky, United States, 41011
      • Research Site
  • Louisiana
    • Alexandria, Louisiana, United States, 71301
      • Research Site
    • Eunice, Louisiana, United States, 70535
      • Research Site
    • Monroe, Louisiana, United States, 71201
      • Research Site
  • Maine
    • Portland, Maine, United States, 04101
      • Research Site
  • Maryland
    • Baltimore, Maryland, United States, 21204
      • Research Site
    • Elkridge, Maryland, United States, 21075
      • Research Site
  • Massachusetts
    • Great Barrington, Massachusetts, United States, 01230
      • Research Site
    • Natick, Massachusetts, United States, 01760
      • Research Site
    • Worcester, Massachusetts, United States, 01655
      • Research Site
  • Michigan
    • Alpena, Michigan, United States, 49707
      • Research Site
    • Detroit, Michigan, United States, 48236
      • Research Site
    • Flint, Michigan, United States, 48504
      • Research Site
    • Grand Rapids, Michigan, United States, 49546
      • Research Site
    • Lansing, Michigan, United States, 48912
      • Research Site
  • Minnesota
    • Coon Rapids, Minnesota, United States, 55433
      • Research Site
    • Minneapolis, Minnesota, United States, 55407
      • Research Site
  • Mississippi
    • Port Gibson, Mississippi, United States, 39150
      • Research Site
  • Missouri
    • Columbia, Missouri, United States, 65212
      • Research Site
    • Saint Louis, Missouri, United States, 63141
      • Research Site
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Research Site
    • Lincoln, Nebraska, United States, 68526
      • Research Site
    • Omaha, Nebraska, United States, 68144
      • Research Site
  • Nevada
    • Las Vegas, Nevada, United States, 89117
      • Research Site
  • New Jersey
    • Cedar Knolls, New Jersey, United States, 07927
      • Research Site
  • New York
    • Albany, New York, United States, 12206
      • Research Site
    • Buffalo, New York, United States, 14215
      • Research Site
    • Kingston, New York, United States, 12401
      • Research Site
    • Rochester, New York, United States, 14642
      • Research Site
  • North Carolina
    • Greensboro, North Carolina, United States, 27401
      • Research Site
    • Wilmington, North Carolina, United States, 28401
      • Research Site
    • Winston-Salem, North Carolina, United States, 27157
      • Research Site
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Research Site
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Research Site
    • Columbus, Ohio, United States, 43214
      • Research Site
    • Columbus, Ohio, United States, 43231
      • Research Site
    • Dayton, Ohio, United States, 45406
      • Research Site
  • Pennsylvania
    • Downingtown, Pennsylvania, United States, 19335
      • Research Site
    • Doylestown, Pennsylvania, United States, 18901
      • Research Site
    • Jersey Shore, Pennsylvania, United States, 17740
      • Research Site
    • Levittown, Pennsylvania, United States, 19056
      • Research Site
    • Wynnewood, Pennsylvania, United States, 19096
      • Research Site
  • Rhode Island
    • Providence, Rhode Island, United States, 02908
      • Research Site
    • Providence, Rhode Island, United States, 02906
      • Research Site
  • South Carolina
    • Charleston, South Carolina, United States, 29412
      • Research Site
    • Greer, South Carolina, United States, 29651
      • Research Site
    • Murrells Inlet, South Carolina, United States, 29576
      • Research Site
    • Summerville, South Carolina, United States, 29485
      • Research Site
  • Tennessee
    • Oak Ridge, Tennessee, United States, 37830
      • Research Site
  • Texas
    • Dallas, Texas, United States, 75235
      • Research Site
    • Houston, Texas, United States, 77061
      • Research Site
    • Humble, Texas, United States, 77338
      • Research Site
    • Kingwood, Texas, United States, 77339
      • Research Site
    • Lufkin, Texas, United States, 75904
      • Research Site
    • McKinney, Texas, United States, 75071
      • Research Site
    • Mesquite, Texas, United States, 75149
      • Research Site
    • Missouri City, Texas, United States, 77459
      • Research Site
    • Sugar Land, Texas, United States, 77478
      • Research Site
    • Tomball, Texas, United States, 77375
      • Research Site
  • Virginia
    • Hopewell, Virginia, United States, 23860
      • Research Site
    • Norfolk, Virginia, United States, 23510
      • Research Site
    • Winchester, Virginia, United States, 22601
      • Research Site
  • Washington
    • Bellevue, Washington, United States, 98004
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Low-density lipoprotein (LDL) treatment patterns	Describe low-density lipoprotein (LDL) treatment patterns over time in subjects with clinical ASCVD	Through study completion, an average of 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LDL-C levels and measurement patterns	Describe LDL-C levels and measurement patterns in subjects with clinical ASCVD	Through study completion, an average of 3 years
Subject Characteristics	Describe subject characteristics	Through study completion, an average of 3 years
Subject understanding of CV risk	Describe subject understanding of CV risk	Through study completion, an average of 3 years
Goals of Lipid Management	Describe subject goals of lipid management	Through study completion, an average of 3 years
Attitudes towards lipid lowering treatment (LLT)	Describe subject attitudes towards lipid lowering treatment (LLT)	Through study completion, an average of 3 years
Percentage of Subjects Achieving Pre-Specified Levels Low-Density Lipoprotein Cholesterol (LDL-C) Before and After Educational Intervention	The two levels of LDL-C that will be assessed are < 70 mg/dL and < 55 mg/dL.	Up to 1 Year
Number of Subjects who Experience an Intensification in Lipid-Lowering Therapy Before and After Educational Intervention		Up to 1 Year
Percentage of Subjects on Optimal Medical Therapy Before and After Educational Intervention		Up to 1 Year
Percentage of Physicians Stating a Specific Lipid Treatment Objective Before and After Educational Intervention		Up to 1 Year

Collaborators and Investigators

• Sponsor: Amgen

Publications and helpful links

General Publications

• Arnold SV, de Lemos JA, Rosenson RS, Ballantyne CM, Liu Y, Mues KE, Alam S, Elliott-Davey M, Bhatt DL, Cannon CP, Kosiborod M; GOULD Investigators. Use of Guideline-Recommended Risk Reduction Strategies Among Patients With Diabetes and Atherosclerotic Cardiovascular Disease. Circulation. 2019 Aug 13;140(7):618-620. doi: 10.1161/CIRCULATIONAHA.119.041730. Epub 2019 Jun 7. No abstract available.
• Arnold SV, Cannon CP, de Lemos JA, Rosenson RS, Ballantyne CM, Liu Y, Alam S, Mues KE, Bhatt DL, Kosiborod M; GOULD Investigators. What Do US Physicians and Patients Think About Lipid-Lowering Therapy and Goals of Treatment? Results From the GOULD Registry. J Am Heart Assoc. 2021 Aug 17;10(16):e020893. doi: 10.1161/JAHA.120.020893. Epub 2021 Aug 7.
• Cannon CP, de Lemos JA, Rosenson RS, Ballantyne CM, Liu Y, Yazdi D, Elliott-Davey M, Mues KE, Bhatt DL, Kosiborod MN; GOULD Investigators. Getting to an ImprOved Understanding of Low-Density Lipoprotein-Cholesterol and Dyslipidemia Management (GOULD): Methods and baseline data of a registry of high cardiovascular risk patients in the United States. Am Heart J. 2020 Jan;219:70-77. doi: 10.1016/j.ahj.2019.10.014. Epub 2019 Oct 31.
• Arnold SV, de Lemos JA, Liu Y, Mues KE, Bhatt DL, Cannon CP, Kosiborod M. Adherence to Guideline Medication Recommendations to Prevent Atherosclerotic Cardiovascular Disease Progression Among Adults With Prior Myocardial Infarction. JAMA Netw Open. 2020 Apr 1;3(4):e203032. doi: 10.1001/jamanetworkopen.2020.3032.
• Shaik A, Kosiborod M, de Lemos JA, Gao Q, Mues KE, Alam S, Bhatt DL, Cannon CP, Ballantyne CM, Rosenson RS; GOULD Investigators. Use of lipid-lowering therapies in patients with chronic kidney disease and atherosclerotic cardiovascular disease: 2-year results from Getting to an imprOved Understanding of Low-Density lipoprotein cholesterol and dyslipidemia management (GOULD). Clin Cardiol. 2022 Dec;45(12):1303-1310. doi: 10.1002/clc.23923. Epub 2022 Sep 19.
• Arnold SV, de Lemos JA, Zheng L, Rosenson RS, Ballantyne CM, Alam S, Bhatt DL, Cannon CP, Kosiborod M; GOULD Investigators. Use of optimal medical therapy in patients with diabetes and atherosclerotic cardiovascular disease: Insights from a prospective longitudinal cohort study. Diabetes Obes Metab. 2023 Feb 27. doi: 10.1111/dom.15032. Online ahead of print.
• Peterson BE, Bhatt DL, Ballantyne CM, de Lemos JA, Rosenson RS, Kosiborod MN, Cannon CP; GOULD Investigators. Intensity of Lipid-Lowering Therapy Among Patients With Polyvascular Disease. JAMA Netw Open. 2023 Mar 1;6(3):e234709. doi: 10.1001/jamanetworkopen.2023.4709.

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2016
• Primary Completion (Actual): August 6, 2021
• Study Completion (Actual): August 6, 2021

Study Registration Dates

• First Submitted: December 2, 2016
• First Submitted That Met QC Criteria: December 12, 2016
• First Posted (Estimate): December 15, 2016

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: April 29, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: 20150230

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR