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

Dyslipidemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02993120
• Other study ID #: 20150230
• Status: Completed
• Start date: December 6, 2016
• Est. completion date: August 6, 2021

Study information

• Verified date: April 2023
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5006
• Est. completion date: August 6, 2021
• Est. primary completion date: August 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• ASCVD Management
• Dyslipidemia
• Dyslipidemias
• Medical Conditions to be Studied

Locations

Country	Name	City	State
United States	Research Site	Albany	New York
United States	Research Site	Alexandria	Louisiana
United States	Research Site	Alpena	Michigan
United States	Research Site	Arlington Heights	Illinois
United States	Research Site	Baltimore	Maryland
United States	Research Site	Bellevue	Washington
United States	Research Site	Bloomfield	Connecticut
United States	Research Site	Boca Raton	Florida
United States	Research Site	Boise	Idaho
United States	Research Site	Brandon	Florida
United States	Research Site	Bridgeport	Connecticut
United States	Research Site	Brooksville	Florida
United States	Research Site	Buffalo	New York
United States	Research Site	Canoga Park	California
United States	Research Site	Cedar Knolls	New Jersey
United States	Research Site	Cerritos	California
United States	Research Site	Chandler	Arizona
United States	Research Site	Charleston	South Carolina
United States	Research Site	Chicago	Illinois
United States	Research Site	Chicago	Illinois
United States	Research Site	Coeur d'Alene	Idaho
United States	Research Site	Colorado Springs	Colorado
United States	Research Site	Colorado Springs	Colorado
United States	Research Site	Columbia	Missouri
United States	Research Site	Columbus	Ohio
United States	Research Site	Columbus	Ohio
United States	Research Site	Columbus	Ohio
United States	Research Site	Coon Rapids	Minnesota
United States	Research Site	Covington	Kentucky
United States	Research Site	Cumming	Georgia
United States	Research Site	Dallas	Texas
United States	Research Site	Davenport	Iowa
United States	Research Site	Dayton	Ohio
United States	Research Site	Daytona Beach	Florida
United States	Research Site	Des Moines	Iowa
United States	Research Site	Detroit	Michigan
United States	Research Site	Downingtown	Pennsylvania
United States	Research Site	Doylestown	Pennsylvania
United States	Research Site	Elkridge	Maryland
United States	Research Site	Eunice	Louisiana
United States	Research Site	Evanston	Illinois
United States	Research Site	Evansville	Indiana
United States	Research Site	Fargo	North Dakota
United States	Research Site	Flint	Michigan
United States	Research Site	Glendale	Arizona
United States	Research Site	Grand Rapids	Michigan
United States	Research Site	Great Barrington	Massachusetts
United States	Research Site	Greensboro	North Carolina
United States	Research Site	Greer	South Carolina
United States	Research Site	Hartford	Connecticut
United States	Research Site	Hollywood	Florida
United States	Research Site	Homestead	Florida
United States	Research Site	Hopewell	Virginia
United States	Research Site	Houston	Texas
United States	Research Site	Humble	Texas
United States	Research Site	Jacksonville	Florida
United States	Research Site	Jacksonville	Florida
United States	Research Site	Jacksonville Beach	Florida
United States	Research Site	Jersey Shore	Pennsylvania
United States	Research Site	Kingston	New York
United States	Research Site	Kingwood	Texas
United States	Research Site	Lafayette	Colorado
United States	Research Site	Lansing	Michigan
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Levittown	Pennsylvania
United States	Research Site	Lincoln	Nebraska
United States	Research Site	Lincoln	Nebraska
United States	Research Site	Los Angeles	California
United States	Research Site	Lufkin	Texas
United States	Research Site	McKinney	Texas
United States	Research Site	Meridian	Idaho
United States	Research Site	Mesquite	Texas
United States	Research Site	Miami	Florida
United States	Research Site	Miami	Florida
United States	Research Site	Miami	Florida
United States	Research Site	Miami	Florida
United States	Research Site	Miami	Florida
United States	Research Site	Miami	Florida
United States	Research Site	Miami Beach	Florida
United States	Research Site	Michigan City	Indiana
United States	Research Site	Minneapolis	Minnesota
United States	Research Site	Missouri City	Texas
United States	Research Site	Monroe	Louisiana
United States	Research Site	Morton	Illinois
United States	Research Site	Murrells Inlet	South Carolina
United States	Research Site	Nampa	Idaho
United States	Research Site	Naples	Florida
United States	Research Site	Natick	Massachusetts
United States	Research Site	Norfolk	Virginia
United States	Research Site	Oak Ridge	Tennessee
United States	Research Site	Omaha	Nebraska
United States	Research Site	Oxnard	California
United States	Research Site	Pembroke Pines	Florida
United States	Research Site	Pensacola	Florida
United States	Research Site	Port Gibson	Mississippi
United States	Research Site	Portland	Maine
United States	Research Site	Providence	Rhode Island
United States	Research Site	Providence	Rhode Island
United States	Research Site	Rancho Mirage	California
United States	Research Site	Rochester	New York
United States	Research Site	Rockledge	Florida
United States	Research Site	Sacramento	California
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Smyrna	Georgia
United States	Research Site	Stamford	Connecticut
United States	Research Site	Sugar Land	Texas
United States	Research Site	Summerville	South Carolina
United States	Research Site	Tomball	Texas
United States	Research Site	Tucson	Arizona
United States	Research Site	Tucson	Arizona
United States	Research Site	Tucson	Arizona
United States	Research Site	Wildomar	California
United States	Research Site	Wilmington	North Carolina
United States	Research Site	Winchester	Virginia
United States	Research Site	Winston-Salem	North Carolina
United States	Research Site	Winter Park	Florida
United States	Research Site	Worcester	Massachusetts
United States	Research Site	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Subject Characteristics	Describe subject characteristics	Through study completion, an average of 3 years
Secondary	Subject understanding of CV risk	Describe subject understanding of CV risk	Through study completion, an average of 3 years
Secondary	Goals of Lipid Management	Describe subject goals of lipid management	Through study completion, an average of 3 years
Secondary	Attitudes towards lipid lowering treatment (LLT)	Describe subject attitudes towards lipid lowering treatment (LLT)	Through study completion, an average of 3 years
Secondary	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
Secondary	Number of Subjects who Experience an Intensification in Lipid-Lowering Therapy Before and After Educational Intervention		Up to 1 Year
Secondary	Percentage of Subjects on Optimal Medical Therapy Before and After Educational Intervention		Up to 1 Year
Secondary	Percentage of Physicians Stating a Specific Lipid Treatment Objective Before and After Educational Intervention		Up to 1 Year

External Links

•   AmgenTrials clinical trials website