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 type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Describe low-density lipoprotein (LDL) treatment patterns over time in subjects with clinical atherosclerotic cardiovascular disease (ASCVD)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  This is a multi-centre observational cohort study with both Retrospective and Prospective data collection components in subjects with ASCVD.

Study drug and medical condition

• Medical condition to be studied:
  Dyslipidaemia

  Cardiovascular disorder

Population studied

• Short description of the study population:
  The study population will include subjects with ASCVD in the US. ; ; Inclusion Criteria; Subject;  ≥ 18 years of age at signing of informed consent;  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 (., aortic aneurysm, ankle brachial index < 0.9, imaging evidence of > 50% stenosis in any peripheral artery, or intermittent claudication); o carotid artery stenosis; Cohorts;  For the cohort of approximately 500 subjects taking a PCSK9i at baseline: evidence of a current prescription for an approved PCSK9i and subject confirmation that they have taken a PCSK9i within 30 days prior to enrollment;  For the cohort of approximately 2000 subjects with LDL-C ≥ 100 mg/dL at last measurement: confirmation of LDL-C ≥100 mg/dL with no change in LLT for 4 weeks (statin and other non-statin therapies). For the cohort of approximately 2500 subjects with LDL-C 70-99 mg/dL at last measurement: 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;  Life expectancy <12 months;  Currently pregnant, breast feeding, or planning to become pregnant*
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Atherosclerotic cardiovascular disease patients
• Estimated number of subjects:
  5000

Study design details

• Main study objective:
  Describe low-density lipoprotein (LDL) treatment patterns over time in subjects with clinical atherosclerotic cardiovascular disease (ASCVD)
• Outcomes:
  • changes in LLT • initiating or discontinuing statin therapy • increasing or decreasing the dose of a statin • switching to a different statin • initiating or discontinuing ezetimibe • initiating or discontinuing a PCSK9i • increasing or decreasing the dose of a PCSK9i • switching to a different PCSK9i • change in other LLT (defined as BAS, prescription LLT, mipomersen, lomitapide, • whether or not LDL-C (mg/dL) and other lipid values as measured, and if so, date and value (mg/dL) • Physician-level Questionnaire • lipid treatment objective in subjects with ASCVD o lower LDL-C o manage other lipid parameters o treating subjects with any dose of statin therapy o treating subjects with maximally tolerated statin therapy o reduce CV risk o other • Subject -level
• Data analysis plan:
  A baseline analysis will be conducted after the last subject enrolled. Additional data analyses will be conducted on periodic basis throughout study period.

Documents

Study results

20150230 ORSR Abstract_Redacted