Medical Conditions to be StudiedNCT02993120
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
An observational study of Medical Conditions to be Studied and Dyslipidemia, run by Amgen at 118 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Medical Conditions to be Studied, Dyslipidemia, ASCVD Management
- How many people
- 5,006 participants
- Where
- 118 sitesUnited States
- Study dates
- 6 Dec 2016to 6 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Adults (18-44 years) * Adults (45-64 years) * Adults (65-74 years) * Adults (75 years and older) * Sex: Male and Female
Who may be able to join
- 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:
Show all 17Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
118 sites in 1 country.
118 sites in 1 country
United States118 sites
Research Site
Albany, New York, 12206
Research Site
Alexandria, Louisiana, 71301
Research Site
Alpena, Michigan, 49707
Research Site
Arlington Heights, Illinois, 60005
Research Site
Baltimore, Maryland, 21204
Research Site
Bellevue, Washington, 98004
Research Site
Bloomfield, Connecticut, 06002
Research Site
Boca Raton, Florida, 33434
Research Site
Boise, Idaho, 83712
Research Site
Brandon, Florida, 33511
Research Site
Bridgeport, Connecticut, 06610
Research Site
Brooksville, Florida, 34601
Research Site
Buffalo, New York, 14215
Research Site
Canoga Park, California, 91303
Research Site
Cedar Knolls, New Jersey, 07927
Research Site
Cerritos, California, 90703
Research Site
Chandler, Arizona, 85224
Research Site
Charleston, South Carolina, 29412
Research Site
Chicago, Illinois, 60604
Research Site
Chicago, Illinois, 60637
Research Site
Coeur d'Alene, Idaho, 83814
Research Site
Colorado Springs, Colorado, 80906
Research Site
Colorado Springs, Colorado, 80909
Research Site
Columbia, Missouri, 65212
Research Site
Columbus, Ohio, 43205
Research Site
Columbus, Ohio, 43214
Research Site
Columbus, Ohio, 43231
Research Site
Coon Rapids, Minnesota, 55433
Research Site
Covington, Kentucky, 41011
Research Site
Cumming, Georgia, 30041
Research Site
Dallas, Texas, 75235
Research Site
Davenport, Iowa, 52803
Research Site
Dayton, Ohio, 45406
Research Site
Daytona Beach, Florida, 32114
Research Site
Des Moines, Iowa, 50309
Research Site
Detroit, Michigan, 48236
Research Site
Downingtown, Pennsylvania, 19335
Research Site
Doylestown, Pennsylvania, 18901
Research Site
Elkridge, Maryland, 21075
Research Site
Eunice, Louisiana, 70535
Research Site
Evanston, Illinois, 60201
Research Site
Evansville, Indiana, 47713
Research Site
Fargo, North Dakota, 58103
Research Site
Flint, Michigan, 48504
Research Site
Glendale, Arizona, 85306
Research Site
Grand Rapids, Michigan, 49546
Research Site
Great Barrington, Massachusetts, 01230
Research Site
Greensboro, North Carolina, 27401
Research Site
Greer, South Carolina, 29651
Research Site
Hartford, Connecticut, 06102
Research Site
Hollywood, Florida, 33021
Research Site
Homestead, Florida, 33030
Research Site
Hopewell, Virginia, 23860
Research Site
Houston, Texas, 77061
Research Site
Humble, Texas, 77338
Research Site
Jacksonville, Florida, 32256
Research Site
Jacksonville, Florida, 32277
Research Site
Jacksonville Beach, Florida, 32250
Research Site
Jersey Shore, Pennsylvania, 17740
Research Site
Kingston, New York, 12401
Research Site
Kingwood, Texas, 77339
Research Site
Lafayette, Colorado, 80026
Research Site
Lansing, Michigan, 48912
Research Site
Las Vegas, Nevada, 89117
Research Site
Levittown, Pennsylvania, 19056
Research Site
Lincoln, Nebraska, 68510
Research Site
Lincoln, Nebraska, 68526
Research Site
Los Angeles, California, 90048
Research Site
Lufkin, Texas, 75904
Research Site
McKinney, Texas, 75071
Research Site
Meridian, Idaho, 83642
Research Site
Mesquite, Texas, 75149
Research Site
Miami, Florida, 33015
Research Site
Miami, Florida, 33122
Research Site
Miami, Florida, 33126
Research Site
Miami, Florida, 33135
Research Site
Miami, Florida, 33155
Research Site
Miami, Florida, 33165
Research Site
Miami Beach, Florida, 33140
Research Site
Michigan City, Indiana, 46360
Research Site
Minneapolis, Minnesota, 55407
Research Site
Missouri City, Texas, 77459
Research Site
Monroe, Louisiana, 71201
Research Site
Morton, Illinois, 61550
Research Site
Murrells Inlet, South Carolina, 29576
Research Site
Nampa, Idaho, 83686
Research Site
Naples, Florida, 34102
Research Site
Natick, Massachusetts, 01760
Research Site
Norfolk, Virginia, 23510
Research Site
Oak Ridge, Tennessee, 37830
Research Site
Omaha, Nebraska, 68144
Research Site
Oxnard, California, 93030
Research Site
Pembroke Pines, Florida, 33028
Research Site
Pensacola, Florida, 32504
Research Site
Port Gibson, Mississippi, 39150
Research Site
Portland, Maine, 04101
Research Site
Providence, Rhode Island, 02906
Research Site
Providence, Rhode Island, 02908
Research Site
Rancho Mirage, California, 92270
Research Site
Rochester, New York, 14642
Research Site
Rockledge, Florida, 32955
Research Site
Sacramento, California, 95823
Research Site
Smyrna, Georgia, 30082
Research Site
St Louis, Missouri, 63141
Research Site
Stamford, Connecticut, 06905
Research Site
Sugar Land, Texas, 77478
Research Site
Summerville, South Carolina, 29485
Research Site
Tomball, Texas, 77375
Research Site
Tucson, Arizona, 85712
Research Site
Tucson, Arizona, 85741
Research Site
Tucson, Arizona, 85745
Research Site
Wildomar, California, 92595
Research Site
Wilmington, North Carolina, 28401
Research Site
Winchester, Virginia, 22601
Research Site
Winston-Salem, North Carolina, 27157
Research Site
Winter Park, Florida, 32792
Research Site
Worcester, Massachusetts, 01655
Research Site
Wynnewood, Pennsylvania, 19096
About this study
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.
Read the 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:
- 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;
- 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;
- 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.
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Low-density lipoprotein (LDL) treatment patterns
Describe low-density lipoprotein (LDL) treatment patterns over time in subjects with clinical ASCVD
Measured: Through study completion, an average of 3 years
Secondary outcomes (9)
LDL-C levels and measurement patterns
Describe LDL-C levels and measurement patterns in subjects with clinical ASCVD
Measured: Through study completion, an average of 3 years
Subject Characteristics
Describe subject characteristics
Measured: Through study completion, an average of 3 years
Subject understanding of CV risk
Describe subject understanding of CV risk
Measured: Through study completion, an average of 3 years
Goals of Lipid Management
Describe subject goals of lipid management
Measured: Through study completion, an average of 3 years
Attitudes towards lipid lowering treatment (LLT)
Describe subject attitudes towards lipid lowering treatment (LLT)
Measured: 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.
Measured: Up to 1 Year
Number of Subjects who Experience an Intensification in Lipid-Lowering Therapy Before and After Educational Intervention
Measured: Up to 1 Year
Percentage of Subjects on Optimal Medical Therapy Before and After Educational Intervention
Measured: Up to 1 Year
Percentage of Physicians Stating a Specific Lipid Treatment Objective Before and After Educational Intervention
Measured: Up to 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study start6 Dec 2016
- Primary completion6 Aug 2021
- Study completion6 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Medical Conditions to be StudiedStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 5,006 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02993120
- Sponsor's protocol ID
- 20150230
- Status last verified
- Apr 2023
- First submitted
- 2 Dec 2016
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
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.
PubMed 31174429Arnold 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.
PubMed 34369165Cannon 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.
PubMed 31726422Arnold 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.
PubMed 32301989Shaik 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.
PubMed 36124341Arnold 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.
PubMed 36843558Peterson 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.
PubMed 36972054Cannon CP, Ballantyne CM, Bhatt DL, de Lemos JA, Gao Q, Kui N, Rosenson RS, Mues KE, Exter J, Alam S, Kosiborod MN; GOULD EDU Investigators. GOULD EDU: Cluster-Randomized Trial of an Educational Intervention to Improve Lipid-Lowering Guideline Adherence. JACC Adv. 2026 Jan;5(1):102403. doi: 10.1016/j.jacadv.2025.102403. Epub 2025 Dec 3.
PubMed 41344145
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02993120
- Acronym / sponsor ID
- 20150230
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,006 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2016 (actual)
- Primary completion
- 6 Aug 2021 (actual)
- Study completion
- 6 Aug 2021 (actual)
- First posted
- 15 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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;
- 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;
- 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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Adults (18-44 years) * Adults (45-64 years) * Adults (65-74 years) * Adults (75 years and older) * Sex: Male and Female
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
9 secondary outcomes
LDL-C levels and measurement patterns
Time frame: Through study completion, an average of 3 years
Subject Characteristics
Time frame: Through study completion, an average of 3 years
Subject understanding of CV risk
Time frame: Through study completion, an average of 3 years
Goals of Lipid Management
Time frame: Through study completion, an average of 3 years
Attitudes towards lipid lowering treatment (LLT)
Time frame: 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
Time frame: Up to 1 Year
Number of Subjects who Experience an Intensification in Lipid-Lowering Therapy Before and After Educational Intervention
Time frame: Up to 1 Year
Percentage of Subjects on Optimal Medical Therapy Before and After Educational Intervention
Time frame: Up to 1 Year
Percentage of Physicians Stating a Specific Lipid Treatment Objective Before and After Educational Intervention
Time frame: Up to 1 Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Background: PubMed 31174429Arnold 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.
- Background: PubMed 34369165Arnold 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.
- Background: PubMed 31726422Cannon 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.
- Background: PubMed 32301989Arnold 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.
- Background: PubMed 36124341Shaik 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.
- Background: PubMed 36843558Arnold 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.
- Background: PubMed 36972054Peterson 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.
- Derived from this study: PubMed 41344145Cannon CP, Ballantyne CM, Bhatt DL, de Lemos JA, Gao Q, Kui N, Rosenson RS, Mues KE, Exter J, Alam S, Kosiborod MN; GOULD EDU Investigators. GOULD EDU: Cluster-Randomized Trial of an Educational Intervention to Improve Lipid-Lowering Guideline Adherence. JACC Adv. 2026 Jan;5(1):102403. doi: 10.1016/j.jacadv.2025.102403. Epub 2025 Dec 3.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
118 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medical Conditions to be Studied and Dyslipidemia, run by Amgen at 118 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 118 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low-density lipoprotein (LDL) treatment patterns (time frame: Through study completion, an average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02993120, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.