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Study Complete
Sponsor ID
20150230

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

Sponsor ID
20150230
Clinicaltrials.gov ID
NCT02993120
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 4
Product
Evolocumab
Type
Observational
Masking
N/A
Enrollment
5006
Additional Study Details

Protocol Summary

Primary Outcome Measures

Low-density lipoprotein (LDL) treatment patterns

Timeframe: Through study completion, an average of 3 years

Secondary Outcome Measures

LDL-C levels and measurement patterns

Timeframe: Through study completion, an average of 3 years

Subject Characteristics

Timeframe: Through study completion, an average of 3 years

Subject understanding of CV risk

Timeframe: Through study completion, an average of 3 years

Goals of Lipid Management

Timeframe: Through study completion, an average of 3 years

Attitudes towards lipid lowering treatment (LLT)

Timeframe: 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

Timeframe: Up to 1 Year

Number of Subjects who Experience an Intensification in Lipid-Lowering Therapy Before and After Educational Intervention

Timeframe: Up to 1 Year

Percentage of Subjects on Optimal Medical Therapy Before and After Educational Intervention

Timeframe: Up to 1 Year

Percentage of Physicians Stating a Specific Lipid Treatment Objective Before and After Educational Intervention

Timeframe: Up to 1 Year

Locations

Location
Status
Contact Us
Location
Research Site
Morton, IL, United States, 61550
Status
Recruiting
Location
Research Site
Michigan City, IN, United States, 46360
Status
Recruiting
Location
Research Site
Hollywood, FL, United States, 33021
Status
Recruiting
Location
Research Site
Alexandria, LA, United States, 71301
Status
Recruiting
Location
Research Site
Alpena, MI, United States, 49707
Status
Recruiting
Location
Research Site
Baltimore, MD, United States, 21204
Status
Recruiting
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Study Info
Age
18 - 99 Years
Condition
  • Cholesterol
    • Show more
  • Cardiovascular Disease
    • Sex
    All
    Trial Dates
    Dec 2016 - Aug 2021
    Inclusion and Exclusion 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: o coronary artery disease o prior history of myocardial infarction o coronary or other arterial revascularization o ischemic stroke or transient ischemic attack o 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) o carotid artery stenosis o 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