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
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02993120|
Recruitment Status : Active, not recruiting
First Posted : December 15, 2016
Last Update Posted : February 21, 2021
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.
|Condition or disease|
|Medical Conditions to be Studied Dyslipidemia ASCVD Management|
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:
- 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;
- 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;
- 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.
|Study Type :||Observational|
|Actual Enrollment :||5006 participants|
|Official Title:||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|
|Actual Study Start Date :||December 6, 2016|
|Estimated Primary Completion Date :||July 30, 2021|
|Estimated Study Completion Date :||July 30, 2021|
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
- Low-density lipoprotein (LDL) treatment patterns [ Time Frame: Through study completion, an average of 3 years ]Describe low-density lipoprotein (LDL) treatment patterns over time in subjects with clinical ASCVD
- LDL-C levels and measurement patterns [ Time Frame: Through study completion, an average of 3 years ]Describe LDL-C levels and measurement patterns in subjects with clinical ASCVD
- Subject Characteristics [ Time Frame: Through study completion, an average of 3 years ]Describe subject characteristics
- Subject understanding of CV risk [ Time Frame: Through study completion, an average of 3 years ]Describe subject understanding of CV risk
- Goals of Lipid Management [ Time Frame: Through study completion, an average of 3 years ]Describe subject goals of lipid management
- Attitudes towards lipid lowering treatment (LLT) [ Time Frame: Through study completion, an average of 3 years ]Describe subject attitudes towards lipid lowering treatment (LLT)
- Percentage of Subjects Achieving Pre-Specified Levels Low-Density Lipoprotein Cholesterol (LDL-C) Before and After Educational Intervention [ Time Frame: Up to 1 Year ]The two levels of LDL-C that will be assessed are < 70 mg/dL and < 55 mg/dL.
- Number of Subjects who Experience an Intensification in Lipid-Lowering Therapy Before and After Educational Intervention [ Time Frame: Up to 1 Year ]
- Percentage of Subjects on Optimal Medical Therapy Before and After Educational Intervention [ Time Frame: Up to 1 Year ]
- Percentage of Physicians Stating a Specific Lipid Treatment Objective Before and After Educational Intervention [ Time Frame: Up to 1 Year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02993120