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

NCT05263778 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: 1824539
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; NSTEMI; STEMI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• To determine the efficacy of BA/E vs. matching placebo on the lipid profile following a recent ACS event.

  0-12 weeks

• To determine the efficacy of BA/E vs. matching placebo on the lipid profile following a recent ACS event.

  0-12 weeks

• To determine the efficacy of BA/E vs. matching placebo on the lipid profile following a recent ACS event.

  0-12 weeks

• To determine the efficacy of BA/E vs. matching placebo on the lipid profile following a recent ACS event.

  0-12 weeks

Other Outcomes (6)

• To assess the safety and tolerability of BA/E vs. matching placebo following a recent ACS event.

  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.

  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.

  0-12 weeks

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Bempedoic acid 180 mg/ezetimibe 10 mg

Drug: Bempedoic Acid / Ezetimibe Oral Tablet

Placebo

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo

Interventions

Bempedoic Acid / Ezetimibe Oral Tablet DRUG

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

Also known as: Nexlizet

Intervention

Placebo DRUG

Matching placebo by mouth once daily for 12 weeks

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead
• Esperion Therapeutics, Inc.: collaborator

Study Sites (1)

Kaiser Permanente Northern California Division of Research

Oakland, California, 94612, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Non-ST Elevated Myocardial Infarction; ST Elevation Myocardial Infarction

Interventions

8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid; Ezetimibe

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Andrew P Ambrosy, MD

  Kaiser Permanente Northern California Division of Research

  PRINCIPAL INVESTIGATOR

• Alan S Go, MD

  Kaiser Permanente Northern California Division of Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew P Ambrosy, MD

CONTACT

415-271-9703; Andrew.P.Ambrosy@kp.org

Alan S Go, MD

CONTACT

510-891-3422; Alan.S.Go@kp.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pragmatic randomized clinical trial

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: March 3, 2022
• Study Start: March 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 3, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)