Status:
COMPLETED
Process Versus Outcomes Incentives for Lipid Management
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Rutgers University
University of California, San Francisco
Conditions:
Diabetes
Cardiovascular Disease
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
In a 4-arm, randomized controlled trial, we will evaluate the relative effectiveness and cost-effectiveness of improving cholesterol levels among participants who are at high risk of CVD and who have ...
Eligibility Criteria
Inclusion
- Individuals at high risk of a cardiac event, specifically one of the following:
- Individuals with clinical ASCVD (defined as diagnosis with myocardial infarction, stroke, or peripheral vascular disease) with an LDL greater than or equal to 100 mg/dl ;
- Individuals with Diabetes (between the ages of 40-75) with an LDL greater than or equal to 100 mg/dl;
- Individuals without clinical ASCVD or diabetes with LDLC with an LDL greater than or equal to 100 mg/dl and estimated 10-year ASCVD risk 7.5%;
- Individuals without clinical ASCVD or diabetes with LDL cholesterol 190 mg/dl
- A prescription filled for a statin medication within the last 12 months (derived from pharmacy records);
- Low medication adherence on self-report completed during enrollment
Exclusion
- Under 18 years old
- A contraindication to further statin use or have suffered statin side effects, such as myopathy
- Will not or cannot give consent
- A history of active or progressive liver disease
- Participating in another clinical trial with related aims
- Co-morbidities likely to lead to death within a short period (e.g. metastatic cancer)
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2018
Estimated Enrollment :
764 Patients enrolled
Trial Details
Trial ID
NCT02246959
Start Date
February 1 2015
End Date
October 1 2018
Last Update
February 26 2019
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104