Evaluation of Major Cardiovascular Events in Participants With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Esperion Therapeutics, Inc.
With
The Cleveland Clinic
Age
18–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Evaluation of Major Cardiovascular Events in Participants With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo
