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:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2025-12-26 @ 10:59 AM
NCT ID:
NCT02993406
Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 85 years
* History of, or at high risk for, cardiovascular disease (CVD) including coronary artery disease, symptomatic peripheral arterial disease, cerebrovascular atherosclerotic disease, or at high risk for a cardiovascular event
* Participant-reported SI due to an adverse safety effect that started or increased during statin therapy and resolved or improved when statin therapy was discontinued resulting in an inability to tolerate:
* 2 or more statins at any dose, or
* 1 statin at any dose and unwilling to attempt a second statin or advised by a physician to not attempt a second statin.
Please note that participants currently tolerating very low dose statin therapy (an average daily dose of rosuvastatin \<5 mg, atorvastatin \<10 mg, simvastatin \<10 mg, lovastatin \<20 mg, pravastatin \<40 mg, fluvastatin \<40 mg, or pitavastatin \<2 mg) are considered to be intolerant to that low dose statin. Patients may continue taking very low dose statin therapy throughout the study provided that it is stable (used for at least 4 weeks prior to screening) and well tolerated.
* Written confirmation by both participant and investigator that the participant is statin intolerant as defined above, aware of the benefit of statin use to reduce the risk of MACE including death, and also aware that many other participants who are unable to tolerate a statin are able to tolerate a different statin or dose.
* Men and nonpregnant, nonlactating women
* Fasting blood LDL-cholesterol ≥ 100 (2.6 mmol/L) at screening
Exclusion Criteria:
* Fasting blood triglycerides greater than 500 mg/dL (5.6 mmol/L) at screening
* Recent (within 90 days of screening) history of major cardiovascular events, transient ischemic attack (TIA), or unstable or symptomatic cardiac arrhythmia
* History of severe heart failure
* Uncontrolled hypertension or uncontrolled diabetes
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT02993406
Study Brief:
Protocol Section:
NCT02993406