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

Completed

Conditions studied: Medical Conditions to be Studied, Dyslipidemia, ASCVD Management

In brief

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.

Key facts

Study ID

NCT02993120

Run by

Amgen

People needed

5006

Starts

2016-12-06

Expected to finish

2021-08-06

Last updated by the study team

2023-05-03

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Research Site — Glendale, Arizona, United States
• Research Site — Tucson, Arizona, United States
• Research Site — Tucson, Arizona, United States
• Research Site — Tucson, Arizona, United States
• Research Site — Canoga Park, California, United States
• Research Site — Cerritos, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Oxnard, California, United States
• Research Site — Rancho Mirage, California, United States
• Research Site — Sacramento, California, United States
• Research Site — Wildomar, California, United States
• Research Site — Colorado Springs, Colorado, United States
• Research Site — Colorado Springs, Colorado, United States
• Research Site — Lafayette, Colorado, United States
• Research Site — Bloomfield, Connecticut, United States
• Research Site — Bridgeport, Connecticut, United States
• Research Site — Hartford, Connecticut, United States
• Research Site — Stamford, Connecticut, United States
• Research Site — Boca Raton, Florida, United States
• Research Site — Brandon, Florida, United States
• Research Site — Brooksville, Florida, United States
• Research Site — Daytona Beach, Florida, United States
• Research Site — Hollywood, Florida, United States
• Research Site — Homestead, Florida, United States
• Research Site — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.