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.
The CLEAR ACS study is a prospective, virtual, electronic health record (EHR)-based, randomized, double-blind, placebo-controlled, parallel-group, pragmatic clinical trial (PCT) embedded within Kaiser Permanente Northern California's fully integrated and learning health care delivery system. The EHR will be screened in real-time for potentially eligible participants across all Kaiser Permanente Northern California hospitals using validated diagnostic and procedural codes, disease registries, laboratory values, pharmacy dispensing information, and sociodemographic data sources. Eligible patients that provide informed consent will be randomized in a 1:1 allocation ratio to an initial 12 weeks of blinded bempedoic acid/ezetimibe (BA/E) vs. matching placebo followed by a 12-week open-label extension phase where all patients will receive open-label, unblinded bempedoic acid/ezetimibe.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
500
Bempedoic acid 180 mg/ezetimibe 10 mg by mouth once daily for 12 weeks
Matching placebo by mouth once daily for 12 weeks
Kaiser Permanente Northern California Division of Research
Oakland, California, United States
To evaluate the efficacy of BA/E vs. matching placebo on LDL-C level following a recent ACS event.
Percent (%) change from baseline to week 12 in LDL-C level
Time frame: 0-12 weeks
To determine the efficacy of BA/E vs. matching placebo on the lipid profile following a recent ACS event.
\- Percent (%) change from baseline to week 12 in high-density lipoprotein cholesterol (HDL-C)
Time frame: 0-12 weeks
To determine the efficacy of BA/E vs. matching placebo on the lipid profile following a recent ACS event.
\- Percent (%) change from baseline to week 12 in non-HDL-C
Time frame: 0-12 weeks
To determine the efficacy of BA/E vs. matching placebo on the lipid profile following a recent ACS event.
\- Percent (%) change from baseline to week 12 in total cholesterol (TC)
Time frame: 0-12 weeks
To determine the efficacy of BA/E vs. matching placebo on the lipid profile following a recent ACS event.
\- Percent (%) change from baseline to week 12 in triglyceride (TGs) levels
Time frame: 0-12 weeks
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