A Phase 4 interventional study of Bempedoic Acid / Ezetimibe Oral Tablet and Placebo in Cardiovascular Diseases, NSTEMI and STEMI, sponsored by Kaiser Permanente. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-03.
Sponsored by Kaiser Permanente · Phase 4, Interventional, and Prevention
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's planned enrollment of 500 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Kaiser Permanente is the lead sponsor of 385 studies on the registry; 41 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Bempedoic acid 180 mg/ezetimibe 10 mg
Drug: Bempedoic Acid / Ezetimibe Oral Tablet
Matching placebo
Drug: Placebo
Bempedoic acid 180 mg/ezetimibe 10 mg by mouth once daily for 12 weeks
Also known as: Nexlizet
Matching placebo by mouth once daily for 12 weeks
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
To assess the safety and tolerability of BA/E vs. matching placebo following a recent ACS event.
- Proportion (%) of adverse events (AEs) leading to permanent study drug discontinuation and unexpected serious AEs (SAEs) at 12 weeks
Time frame: 0-12 weeks
To explore the clinical effectiveness of BA/E vs. usual care on all-cause and cause-specific morbidity and mortality following a recent ACS event.
- Rate (# of events per 100 person-years) of all-cause mortality (ACM)
Time frame: 0-12 weeks
To explore the clinical effectiveness of BA/E vs. usual care on all-cause and cause-specific morbidity and mortality following a recent ACS event.
- Rate (# of events per 100 person-years) of MACE (3-point) = death due to any cause, MI, and/or stroke/TIA
Time frame: 0-12 weeks
To explore the clinical effectiveness of BA/E vs. usual care on all-cause and cause-specific morbidity and mortality following a recent ACS event.
- Rate (# of events per 100 person-years) of MACE (4-point) = MACE (3-point) + hospitalization for unstable angina
Time frame: 0-12 weeks
To explore the clinical effectiveness of BA/E vs. usual care on all-cause and cause-specific morbidity and mortality following a recent ACS event.
- Rate (# of events per 100 person-years) of MACE (5-point) = MACE (4-point) + any coronary revascularization
Time frame: 0-12 weeks
To explore the clinical effectiveness of BA/E vs. usual care on all-cause and cause-specific morbidity and mortality following a recent ACS event.
- Rate (# of events per 100 person-years) of all-cause emergency department (ED) visits + all-cause hospitalizations
Time frame: 0-12 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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