Clinical trial NCT05263778: Cholesterol Lowering Via Bempedoic Acid/Ezetimibe, an ACL-Inhibiting Regimen in Acute Coronary Syndrome Study
Official title: Cholesterol Lowering Via Bempedoic Acid/Ezetimibe, an ACL-Inhibiting Regimen in Acute Coronary Syndrome (CLEAR ACS) Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cardiovascular Diseases
NSTEMI
STEMI
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Esperion Therapeutics, Inc.
First posted: 2022-03-03
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic randomized clinical trial
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Men and women age \>18 years
* Able to provide informed consent
* A documented recent ACS event (i.e., defined as up to 14 days post-discharge from an index hospitalization for a non-ST-elevation MI \[NSTEMI\] or ST-elevation MI \[STEMI\] necessitating urgent and/or emergent percutaneous coronary intervention \[PCI\] and/or coronary after bypass graft \[CABG\])
* At least 6 months of continuous health plan membership and prescription drug benefit prior to enrollment
* A registered e-mail address with Kaiser Permanente in order to obtain electronic consent (eConsent) for study participation

Exclusion Criteria:

* Receipt of BA/E on or within 3 months before the day of enrollment
* A history of hypersensitivity to BA/E
* Women who are pregnant or planning to become pregnant and/or breastfeeding mothers
* A diagnosis of gout and/or previously known laboratory-confirmed hyperuricemia (serum uric acid \>8.0 mg/dL)
* A history of tendon disorders or tendon rupture
* Current and/or planned treatment with simvastatin/pravastatin, cyclosporine, fibrates, and/or bile acid sequestrants (to avoid drug-drug interactions)
* A known life-limiting diagnosis (e.g., stage D heart failure, severe liver disease, end-stage kidney disease \[ESKD\] requiring chronic dialysis or an estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2, metastatic cancer and/or actively receiving systemic chemotherapy)
* Institutionalized and/or receiving palliative care
* Non-English speaking

Primary outcomes:
measure: To evaluate the efficacy of BA/E vs. matching placebo on LDL-C level following a recent ACS event.
timeFrame: 0-12 weeks
Secondary outcomes:
measure: To determine the efficacy of BA/E vs. matching placebo on the lipid profile following a recent ACS event.
timeFrame: 0-12 weeks
measure: To determine the efficacy of BA/E vs. matching placebo on the lipid profile following a recent ACS event.
timeFrame: 0-12 weeks
measure: To determine the efficacy of BA/E vs. matching placebo on the lipid profile following a recent ACS event.
timeFrame: 0-12 weeks
measure: To determine the efficacy of BA/E vs. matching placebo on the lipid profile following a recent ACS event.
timeFrame: 0-12 weeks
Other outcomes:
measure: To assess the safety and tolerability of BA/E vs. matching placebo following a recent ACS event.
timeFrame: 0-12 weeks
measure: 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.
timeFrame: 0-12 weeks
measure: 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.
timeFrame: 0-12 weeks
measure: 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.
timeFrame: 0-12 weeks
measure: 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.
timeFrame: 0-12 weeks
measure: 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.
timeFrame: 0-12 weeks
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente Northern California Division of Research
state: California
Study officials:
affiliation: Kaiser Permanente Northern California Division of Research
name: Andrew P Ambrosy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaiser Permanente Northern California Division of Research
name: Alan S Go, MD
role: PRINCIPAL_INVESTIGATOR
References: