GOAL International QuERI - Protocol CHRC 2019 GOAL INTERNATIONAL
- Conditions
- Dyslipidemia
- Registration Number
- NCT03861533
- Lead Sponsor
- Dr. Anatoly Langer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> 1. Adults = 18 years old<br><br> 2. High risk for cardiovascular morbidity and mortality such as prior history of<br> clinical cardiovascular disease and/or history of familial hypercholesterolemia<br><br> 3. LDL-C within the past 6 months above recommended level despite maximal tolerated<br> statin therapy ± ezetimibe for the past 3 months.<br><br>Exclusion Criteria:<br><br> 1. Current treatment with PCSK9 inhibitor<br><br> 2. Current participation in investigational study<br><br> 3. Prior participation in the GOAL program
Not provided
Study & Design
- Study Type
- Observational [Patient Registry]
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients achieving country specific guideline-recommended LDL-C levels after 18 month final visit or last available observation during follow up visits.
- Secondary Outcome Measures
Name Time Method 1. Relative and absolute reduction of LDL-C with lipid lowering medications added during the observation period.;Proportion of patients not achieving recommended LDL-C level based on high risk inclusion sub-group (e.g. FH), co-morbid conditions (diabetes mellitus), baseline treatment or baseline lipid profile.;Proportion of patients not achieving recommended LDL-C level at each of the follow up visits according to physician responses as to why country specific recommendation for LDL-C lowering opportunities was not followed.;Proportion of patients achieving LDL-C and non-HDL level across participating countries.