NCT02993406CompletedPhase 3
A Randomized, Double-blind, Placebo-controlled Study to Assess the Effects of Bempedoic Acid (ETC-1002) on the Occurrence of Major Cardiovascular Events in Patients With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant
Esperion Therapeutics, Inc.1 site in 1 country13,970 target enrollmentStarted: December 22, 2016Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Esperion Therapeutics, Inc.
- Enrollment
- 13,970
- Locations
- 1
- Primary Endpoint
- Number of Participants With First Occurrence of Four Component Major Adverse Cardiovascular Events (MACE)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Bempedoic Acid 180 mg
Experimental
Bempedoic acid 180 mg tablet taken orally, once daily.
Intervention: Bempedoic acid 180 mg tablet (Drug)
Placebo Comparator
Placebo Comparator
Matching placebo tablet taken orally, once daily
Intervention: Matching placebo tablet (Drug)
Outcomes
Primary Outcomes
Number of Participants With First Occurrence of Four Component Major Adverse Cardiovascular Events (MACE)
Time Frame: Up to 68 months
The primary efficacy end point was a four-component composite of adjudicated MACE, defined as death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization, as assessed in a time-to first-event analysis.
Secondary Outcomes
- Number of Participants With Time to First Occurrence of Coronary Revascularization(Up to 68 months)
- Number of Participants With First Occurrence of Myocardial Infarction(Up to 68 months)
- Number of Participants With First Occurrence of Three Component MACE(Up to 68 months)
- Number of Participants With Time to Cardiovascular Death(Up to 68 months)
- Number of Participants With Time to All-cause Mortality(Up to 68 months)
- Number of Participants With Time to First Occurrence of Stroke(Up to 68 months)
Investigators
Study Sites (1)
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