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 identification

• PURI:
  https://redirect.ema.europa.eu/resource/46756
• EU PAS number:
  EUPAS16291
• Study ID:
  46756
• Official title and acronym:
  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
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Primary Objective: • Describe low-density lipoprotein (LDL) treatment patterns over time in subjects with clinical atherosclerotic cardiovascular disease (ASCVD) Secondary Objectives: • Describe (LDL-C) levels and measurement patterns in subjects with clinical ASCVD • Describe subject characteristics • Describe subject understanding of CV risk, goals of lipid management and attitudes towards lipid lowering treatment (LLT) Exploratory Objectives: • Estimate the effect of subject, physician, and site factors on LLT patterns • Describe management of statin intolerance • Describe changes in LLT patterns after the release of updated lipid management guidelines and/or new clinical study data
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Multiple centres: 120 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 15/03/2016

Actual: 15/03/2016

Study start date

Planned: 09/12/2016

Actual: 06/12/2016

Data analysis start date

Planned: 22/09/2021

Actual: 30/09/2021

Date of final study report

Planned: 25/03/2022

Actual: 12/04/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

Repatha 20150230 Original Protocol_14AUG2016 redacted 10 17 2016 final for PASS

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable