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

Conditions

• Cardiovascular Diseases
• Statin Adverse Reaction

Eligibility Criteria

Sex

ALL

Age

18 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• Bempedoic acid 180 mg tablet — DRUG
  Patients take bempedoic acid 180 mg tablet orally once daily
• Matching placebo tablet — DRUG
  Patients take matching placebo tablet orally once daily

Study Details

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.

Key Dates

Start date

Dec 22, 2016

Status verified

Dec 2023

Primary completion

Nov 7, 2022

Completion

Nov 7, 2022

Study Design

Enrollment

13,970 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Bempedoic Acid 180 mg
  Bempedoic acid 180 mg tablet taken orally, once daily.
• Placebo Comparator: Placebo Comparator
  Matching placebo tablet taken orally, once daily

Primary Outcome Measure

Number of Participants With First Occurrence of Four Component Major Adverse Cardiovascular Events (MACE) [ Time Frame: Up to 68 months ]

Locations (304)

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