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

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:

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.

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* *While subjects
that are pregnant are not eligible for the study, if a site investigator has a subject
that becomes pregnant while receiving evolocumab, they will be advised to refer the
subject to Amgen's evolocumab pregnancy registry