Cholesterol Lowering Via Bempedoic Acid/Ezetimibe, an ACL-Inhibiting Regimen in Acute Coronary Syndrome Study
Part of paid clinical trials in Oakland, California.
- Sponsor
- Kaiser Permanente
- Study ID
- NCT05263778
- Phase
- PHASE4
- Status
- Unknown
Conditions
- Cardiovascular Diseases
- NSTEMI
- STEMI
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Bempedoic Acid / Ezetimibe Oral Tablet — DRUGBempedoic acid 180 mg/ezetimibe 10 mg by mouth once daily for 12 weeks
- Placebo — DRUGMatching placebo by mouth once daily for 12 weeks
Study Details
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.
Key Dates
- Start date
- Mar 31, 2022
- Status verified
- Mar 2022
- Primary completion
- Jun 30, 2023
- Completion
- Dec 31, 2023
Study Design
- Enrollment
- 500 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Active Comparator: InterventionBempedoic acid 180 mg/ezetimibe 10 mg
- Placebo Comparator: PlaceboMatching placebo
Primary Outcome Measure
To evaluate the efficacy of BA/E vs. matching placebo on LDL-C level following a recent ACS event. [ Time Frame: 0-12 weeks ]
Central Contacts
- Andrew P Ambrosy, MD415-271-9703
- Alan S Go, MD510-891-3422
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Kaiser Permanente Northern California Division of Research | Oakland | California | 94612 | Andrew P Ambrosy, MD (PRINCIPAL_INVESTIGATOR) Alan S Go, MD (PRINCIPAL_INVESTIGATOR) |
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