Phase 3
N=13,970
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
Cardiovascular Diseases · Statin Adverse Reaction
Bottom Line
View on ClinicalTrials.gov: NCT02993406 ↗Enrolled (actual)
13,970
Serious AEs
25.1%
Results posted
Jan 2024
Primary outcome: Primary: Number of Participants With First Occurrence of Four Component Major Adverse Cardiovascular Events (MACE) — 819; 927 Participants — p=0.004
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Bempedoic acid 180 mg tablet (Drug); Matching placebo tablet (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Esperion Therapeutics, Inc.
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With First Occurrence of Four Component Major Adverse Cardiovascular Events (MACE) |
819; 927 | 0.004 sig |
| SECONDARY Number of Participants With First Occurrence of Three Component MACE |
575; 663 | 0.0058 sig |
| SECONDARY Number of Participants With First Occurrence of Myocardial Infarction |
261; 334 | 0.0016 sig |
| SECONDARY Number of Participants With Time to First Occurrence of Coronary Revascularization |
435; 529 | 0.0013 sig |
| SECONDARY Number of Participants With Time to First Occurrence of Stroke |
135; 158 | 0.1593 |
| SECONDARY Number of Participants With Time to Cardiovascular Death |
269; 257 | 0.6227 |
| SECONDARY Number of Participants With Time to All-cause Mortality |
434; 420 | 0.6608 |
Summary
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.
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
Data sourced from ClinicalTrials.gov (NCT02993406). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.