Cholesterol Lowering Via Bempedoic Acid/Ezetimibe, an ACL-Inhibiting Regimen in Acute Coronary Syndrome Study

Cardiovascular Diseases Clinical Trial

Official title:

Cholesterol Lowering Via Bempedoic Acid/Ezetimibe, an ACL-Inhibiting Regimen in Acute Coronary Syndrome (CLEAR ACS) Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05263778
• Other study ID #: 1824539
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 2022
• Est. completion date: December 2023

Study information

• Verified date: March 2022
• Source: Kaiser Permanente
• Contact: Andrew P Ambrosy, MD
• Phone: 415-271-9703
• Email: Andrew.P.Ambrosy[@]kp.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Cardiovascular Diseases
• NSTEMI
• STEMI

Intervention

Drug:
• Bempedoic Acid / Ezetimibe Oral Tablet
Bempedoic acid 180 mg/ezetimibe 10 mg by mouth once daily for 12 weeks
• Placebo
Matching placebo by mouth once daily for 12 weeks

Locations

Country	Name	City	State
United States	Kaiser Permanente Northern California Division of Research	Oakland	California

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	Esperion Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	0-12 weeks
Other	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)	0-12 weeks
Other	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	0-12 weeks
Other	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	0-12 weeks
Other	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	0-12 weeks
Other	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	0-12 weeks
Primary	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	0-12 weeks
Secondary	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)	0-12 weeks
Secondary	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	0-12 weeks
Secondary	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)	0-12 weeks
Secondary	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	0-12 weeks