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 Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Medical Conditions to be Studied, Dyslipidemia, ASCVD Management

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>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<br>• 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<br>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?
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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 |