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 (CLEAR Outcomes)

Esperion Therapeutics

Status and phase: Completed; Phase 3

Conditions: Statin Adverse Reaction; Cardiovascular Diseases

Treatments: Drug: Bempedoic acid 180 mg tablet; Drug: Matching placebo tablet

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02993406

1002-043

Details and patient eligibility

About

The purpose of this study is to determine if treatment with bempedoic acid (ETC-1002) versus placebo decreases the risk of cardiovascular events in participants who have or are at high risk for cardiovascular disease and are statin intolerant.

Enrollment: 13,970 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

13,970 participants in 2 patient groups, including a placebo group

Bempedoic Acid 180 mg

Experimental group

Description:

Bempedoic acid 180 mg tablet taken orally, once daily.

Treatment:

Drug: Bempedoic acid 180 mg tablet

Placebo Comparator

Placebo Comparator group

Description:

Matching placebo tablet taken orally, once daily

Treatment:

Drug: Matching placebo tablet