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

NCT ID: NCT05263778

Last Updated: 2022-03-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-31
• Study Completion Date: 2023-12-31

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.

Conditions

Cardiovascular Diseases; NSTEMI; STEMI

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention

Bempedoic acid 180 mg/ezetimibe 10 mg

Group Type: ACTIVE_COMPARATOR

Bempedoic Acid / Ezetimibe Oral Tablet

Intervention Type: DRUG

Bempedoic acid 180 mg/ezetimibe 10 mg by mouth once daily for 12 weeks

Placebo

Matching placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo by mouth once daily for 12 weeks

Interventions

Bempedoic Acid / Ezetimibe Oral Tablet

Bempedoic acid 180 mg/ezetimibe 10 mg by mouth once daily for 12 weeks

Intervention Type: DRUG

Placebo

Matching placebo by mouth once daily for 12 weeks

Intervention Type: DRUG

Other Intervention Names

Nexlizet

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Esperion Therapeutics, Inc.

INDUSTRY

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew P Ambrosy, MD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente Northern California Division of Research

Alan S Go, MD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente Northern California Division of Research

Locations

Kaiser Permanente Northern California Division of Research

Oakland, California, United States

Countries

United States

Central Contacts

Andrew P Ambrosy, MD

Role: CONTACT

Andrew.P.Ambrosy@kp.org

415-271-9703

Alan S Go, MD

Role: CONTACT

Alan.S.Go@kp.org

510-891-3422

Facility Contacts

Rachel C Thomas, RN

Role: primary

Rachel.C.Thomas@kp.org

510-891-3858

Other Identifiers

1824539

Identifier Type: -

Identifier Source: org_study_id