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
NCT ID: NCT02993120
Last Updated: 2023-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
5006 participants
OBSERVATIONAL
2016-12-06
2021-08-06
Brief Summary
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The purpose of this study is to better understand cholesterol treatment patterns in the context of a changing landscape in subjects with ASCVD.
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Detailed Description
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* 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.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* ≥ 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
* 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
18 Years
99 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Chandler, Arizona, United States
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Glendale, Arizona, United States
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Tucson, Arizona, United States
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Tucson, Arizona, United States
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Tucson, Arizona, United States
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Canoga Park, California, United States
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Cerritos, California, United States
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Los Angeles, California, United States
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Oxnard, California, United States
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Rancho Mirage, California, United States
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Sacramento, California, United States
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Wildomar, California, United States
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Colorado Springs, Colorado, United States
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Colorado Springs, Colorado, United States
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Lafayette, Colorado, United States
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Bloomfield, Connecticut, United States
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Bridgeport, Connecticut, United States
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Hartford, Connecticut, United States
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Stamford, Connecticut, United States
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Boca Raton, Florida, United States
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Brandon, Florida, United States
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Brooksville, Florida, United States
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Daytona Beach, Florida, United States
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Hollywood, Florida, United States
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Homestead, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville Beach, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami Beach, Florida, United States
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Naples, Florida, United States
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Pembroke Pines, Florida, United States
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Pensacola, Florida, United States
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Rockledge, Florida, United States
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Winter Park, Florida, United States
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Cumming, Georgia, United States
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Smyrna, Georgia, United States
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Boise, Idaho, United States
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Coeur d'Alene, Idaho, United States
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Meridian, Idaho, United States
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Nampa, Idaho, United States
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Arlington Heights, Illinois, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Evanston, Illinois, United States
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Morton, Illinois, United States
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Evansville, Indiana, United States
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Michigan City, Indiana, United States
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Davenport, Iowa, United States
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Des Moines, Iowa, United States
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Covington, Kentucky, United States
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Alexandria, Louisiana, United States
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Eunice, Louisiana, United States
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Monroe, Louisiana, United States
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Portland, Maine, United States
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Baltimore, Maryland, United States
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Elkridge, Maryland, United States
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Great Barrington, Massachusetts, United States
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Natick, Massachusetts, United States
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Worcester, Massachusetts, United States
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Alpena, Michigan, United States
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Detroit, Michigan, United States
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Flint, Michigan, United States
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Grand Rapids, Michigan, United States
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Lansing, Michigan, United States
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Coon Rapids, Minnesota, United States
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Minneapolis, Minnesota, United States
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Port Gibson, Mississippi, United States
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Columbia, Missouri, United States
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St Louis, Missouri, United States
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Lincoln, Nebraska, United States
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Lincoln, Nebraska, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Cedar Knolls, New Jersey, United States
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Albany, New York, United States
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Buffalo, New York, United States
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Kingston, New York, United States
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Rochester, New York, United States
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Greensboro, North Carolina, United States
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Wilmington, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Fargo, North Dakota, United States
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Columbus, Ohio, United States
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Columbus, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Downingtown, Pennsylvania, United States
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Doylestown, Pennsylvania, United States
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Jersey Shore, Pennsylvania, United States
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Levittown, Pennsylvania, United States
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Wynnewood, Pennsylvania, United States
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Providence, Rhode Island, United States
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Providence, Rhode Island, United States
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Charleston, South Carolina, United States
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Greer, South Carolina, United States
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Murrells Inlet, South Carolina, United States
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Summerville, South Carolina, United States
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Oak Ridge, Tennessee, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Humble, Texas, United States
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Kingwood, Texas, United States
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Lufkin, Texas, United States
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McKinney, Texas, United States
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Mesquite, Texas, United States
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Missouri City, Texas, United States
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Sugar Land, Texas, United States
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Tomball, Texas, United States
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Hopewell, Virginia, United States
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Norfolk, Virginia, United States
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Winchester, Virginia, United States
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Bellevue, Washington, United States
Countries
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References
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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 Jun;25(6):1750-1757. doi: 10.1111/dom.15032. Epub 2023 Mar 7.
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.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20150230
Identifier Type: -
Identifier Source: org_study_id
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