Cholesterol Lowering Via Bempedoic Acid/Ezetimibe, an ACL-Inhibiting Regimen in Acute Coronary Syndrome Study
NCT05263778 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 500
Last updated 2022-03-03
Summary
The overall objective of the Cholesterol Lowering via Bempedoic Acid/Ezetimibe, an ACL-Inhibiting Regimen in Acute Coronary Syndrome ACS (CLEAR ACS) study is to determine the efficacy, safety, and tolerability of bempedoic acid/ezetimibe (BA/E) in a contemporary and real-world population, enriched for older adults, women, and underrepresented racial/ethnic groups, of adults with a recent acute coronary syndrome (ACS) event independent of use of statin therapy before the ACS event.
Conditions
- Cardiovascular Diseases
- NSTEMI
- STEMI
Interventions
- DRUG
-
Bempedoic Acid / Ezetimibe Oral Tablet
Bempedoic acid 180 mg/ezetimibe 10 mg by mouth once daily for 12 weeks
- DRUG
-
Matching placebo by mouth once daily for 12 weeks
Sponsors & Collaborators
-
Esperion Therapeutics, Inc.
collaborator INDUSTRY -
Kaiser Permanente
lead OTHER
Principal Investigators
-
Andrew P Ambrosy, MD · Kaiser Permanente Northern California Division of Research
-
Alan S Go, MD · Kaiser Permanente Northern California Division of Research
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-03-31
- Primary Completion
- 2023-06-30
- Completion
- 2023-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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