Clinical trial NCT02993120: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medical Conditions to be Studied
Dyslipidemia
ASCVD Management
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2016-12-15
Enrollment: 5006
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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

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.

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.

Eligibility 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

Primary outcomes:
measure: Low-density lipoprotein (LDL) treatment patterns
timeFrame: Through study completion, an average of 3 years
Secondary outcomes:
measure: LDL-C levels and measurement patterns
timeFrame: Through study completion, an average of 3 years
measure: Subject Characteristics
timeFrame: Through study completion, an average of 3 years
measure: Subject understanding of CV risk
timeFrame: Through study completion, an average of 3 years
measure: Goals of Lipid Management
timeFrame: Through study completion, an average of 3 years
measure: Attitudes towards lipid lowering treatment (LLT)
timeFrame: Through study completion, an average of 3 years
measure: Percentage of Subjects Achieving Pre-Specified Levels Low-Density Lipoprotein Cholesterol (LDL-C) Before and After Educational Intervention
timeFrame: Up to 1 Year
measure: Number of Subjects who Experience an Intensification in Lipid-Lowering Therapy Before and After Educational Intervention
timeFrame: Up to 1 Year
measure: Percentage of Subjects on Optimal Medical Therapy Before and After Educational Intervention
timeFrame: Up to 1 Year
measure: Percentage of Physicians Stating a Specific Lipid Treatment Objective Before and After Educational Intervention
timeFrame: Up to 1 Year
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Research Site
state: Arizona
city: Glendale
country: United States
facility: Research Site
state: Arizona
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Canoga Park
country: United States
facility: Research Site
state: California
city: Cerritos
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Oxnard
country: United States
facility: Research Site
state: California
city: Rancho Mirage
country: United States
facility: Research Site
state: California
city: Sacramento
country: United States
facility: Research Site
state: California
city: Wildomar
country: United States
facility: Research Site
state: California
city: Colorado Springs
country: United States
facility: Research Site
state: Colorado
city: Colorado Springs
country: United States
facility: Research Site
state: Colorado
city: Lafayette
country: United States
facility: Research Site
state: Colorado
city: Bloomfield
country: United States
facility: Research Site
state: Connecticut
city: Bridgeport
country: United States
facility: Research Site
state: Connecticut
city: Hartford
country: United States
facility: Research Site
state: Connecticut
city: Stamford
country: United States
facility: Research Site
state: Connecticut
city: Boca Raton
country: United States
facility: Research Site
state: Florida
city: Brandon
country: United States
facility: Research Site
state: Florida
city: Brooksville
country: United States
facility: Research Site
state: Florida
city: Daytona Beach
country: United States
facility: Research Site
state: Florida
city: Hollywood
country: United States
facility: Research Site
state: Florida
city: Homestead
country: United States
facility: Research Site
state: Florida
city: Jacksonville Beach
country: United States
facility: Research Site
state: Florida
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Miami Beach
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Naples
country: United States
facility: Research Site
state: Florida
city: Pembroke Pines
country: United States
facility: Research Site
state: Florida
city: Pensacola
country: United States
facility: Research Site
state: Florida
city: Rockledge
country: United States
facility: Research Site
state: Florida
city: Winter Park
country: United States
facility: Research Site
state: Florida
city: Cumming
country: United States
facility: Research Site
state: Georgia
city: Smyrna
country: United States
facility: Research Site
state: Georgia
city: Boise
country: United States
facility: Research Site
state: Idaho
city: Coeur d'Alene
country: United States
facility: Research Site
state: Idaho
city: Meridian
country: United States
facility: Research Site
state: Idaho
city: Nampa
country: United States
facility: Research Site
state: Idaho
city: Arlington Heights
country: United States
facility: Research Site
state: Illinois
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Evanston
country: United States
facility: Research Site
state: Illinois
city: Morton
country: United States
facility: Research Site
state: Illinois
city: Evansville
country: United States
facility: Research Site
state: Indiana
city: Michigan City
country: United States
facility: Research Site
state: Indiana
city: Davenport
country: United States
facility: Research Site
state: Iowa
city: Des Moines
country: United States
facility: Research Site
state: Iowa
city: Covington
country: United States
facility: Research Site
state: Kentucky
city: Alexandria
country: United States
facility: Research Site
state: Louisiana
city: Eunice
country: United States
facility: Research Site
state: Louisiana
city: Monroe
country: United States
facility: Research Site
state: Louisiana
city: Portland
country: United States
facility: Research Site
state: Maine
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Elkridge
country: United States
facility: Research Site
state: Maryland
city: Great Barrington
country: United States
facility: Research Site
state: Massachusetts
city: Natick
country: United States
facility: Research Site
state: Massachusetts
city: Worcester
country: United States
facility: Research Site
state: Massachusetts
city: Alpena
country: United States
facility: Research Site
state: Michigan
city: Detroit
country: United States
facility: Research Site
state: Michigan
city: Flint
country: United States
facility: Research Site
state: Michigan
city: Grand Rapids
country: United States
facility: Research Site
state: Michigan
city: Lansing
country: United States
facility: Research Site
state: Michigan
city: Coon Rapids
country: United States
facility: Research Site
state: Minnesota
city: Minneapolis
country: United States
facility: Research Site
state: Minnesota
city: Port Gibson
country: United States
facility: Research Site
state: Mississippi
city: Columbia
country: United States
facility: Research Site
state: Missouri
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Lincoln
country: United States
facility: Research Site
state: Nebraska
city: Lincoln
country: United States
facility: Research Site
state: Nebraska
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Cedar Knolls
country: United States
facility: Research Site
state: New Jersey
city: Albany
country: United States
facility: Research Site
state: New York
city: Buffalo
country: United States
facility: Research Site
state: New York
city: Kingston
country: United States
facility: Research Site
state: New York
city: Rochester
country: United States
facility: Research Site
state: New York
city: Greensboro
country: United States
facility: Research Site
state: North Carolina
city: Wilmington
country: United States
facility: Research Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Research Site
state: North Carolina
city: Fargo
country: United States
facility: Research Site
state: North Dakota
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Dayton
country: United States
facility: Research Site
state: Ohio
city: Downingtown
country: United States
facility: Research Site
state: Pennsylvania
city: Doylestown
country: United States
facility: Research Site
state: Pennsylvania
city: Jersey Shore
country: United States
facility: Research Site
state: Pennsylvania
city: Levittown
country: United States
facility: Research Site
state: Pennsylvania
city: Wynnewood
country: United States
facility: Research Site
state: Pennsylvania
city: Providence
country: United States
facility: Research Site
state: Rhode Island
city: Providence
country: United States
facility: Research Site
state: Rhode Island
city: Charleston
country: United States
facility: Research Site
state: South Carolina
city: Greer
country: United States
facility: Research Site
state: South Carolina
city: Murrells Inlet
country: United States
facility: Research Site
state: South Carolina
city: Summerville
country: United States
facility: Research Site
state: South Carolina
city: Oak Ridge
country: United States
facility: Research Site
state: Tennessee
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Humble
country: United States
facility: Research Site
state: Texas
city: Kingwood
country: United States
facility: Research Site
state: Texas
city: Lufkin
country: United States
facility: Research Site
state: Texas
city: McKinney
country: United States
facility: Research Site
state: Texas
city: Mesquite
country: United States
facility: Research Site
state: Texas
city: Missouri City
country: United States
facility: Research Site
state: Texas
city: Sugar Land
country: United States
facility: Research Site
state: Texas
city: Tomball
country: United States
facility: Research Site
state: Texas
city: Hopewell
country: United States
facility: Research Site
state: Virginia
city: Norfolk
country: United States
facility: Research Site
state: Virginia
city: Winchester
country: United States
facility: Research Site
state: Virginia
city: Bellevue
country: United States
facility: Research Site
state: Washington
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
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.
citation: 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.
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.
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.
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.
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 Jun;25(6):1750-1757. doi: 10.1111/dom.15032. Epub 2023 Mar 7.
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.