Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-24 @ 2:56 PM
NCT ID:
NCT02246959
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT02246959
Study Brief:
Protocol Section:
NCT02246959