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

Primary Purpose

Cardiovascular Diseases, NSTEMI, STEMI

Status

Not yet recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Bempedoic Acid / Ezetimibe Oral Tablet

Placebo

About this trial

This is an interventional prevention trial for Cardiovascular Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Kaiser Permanente Northern California Division of Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention

Placebo

Arm Description

Bempedoic acid 180 mg/ezetimibe 10 mg

Matching placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

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

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)

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

Full Information

NCT ID

NCT05263778

First Posted

February 14, 2022

Last Updated

March 1, 2022

Sponsor

Kaiser Permanente

Collaborators

Esperion Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05263778

Brief Title

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

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

March 2022 (Anticipated)

Primary Completion Date

June 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kaiser Permanente

Collaborators

Esperion Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiovascular Diseases, NSTEMI, STEMI

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Pragmatic randomized clinical trial

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Active Comparator

Arm Description

Bempedoic acid 180 mg/ezetimibe 10 mg

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Matching placebo

Intervention Type

Drug

Intervention Name(s)

Bempedoic Acid / Ezetimibe Oral Tablet

Other Intervention Name(s)

Nexlizet

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching placebo by mouth once daily for 12 weeks

Primary Outcome Measure Information:

Title

To evaluate the efficacy of BA/E vs. matching placebo on LDL-C level following a recent ACS event.

Description

Percent (%) change from baseline to week 12 in LDL-C level

Time Frame

0-12 weeks

Secondary Outcome Measure Information:

Title

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

Description

- Percent (%) change from baseline to week 12 in high-density lipoprotein cholesterol (HDL-C)

Time Frame

0-12 weeks

Title

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

Description

- Percent (%) change from baseline to week 12 in non-HDL-C

Time Frame

0-12 weeks

Title

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

Description

- Percent (%) change from baseline to week 12 in total cholesterol (TC)

Time Frame

0-12 weeks

Title

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

Description

- Percent (%) change from baseline to week 12 in triglyceride (TGs) levels

Time Frame

0-12 weeks

Other Pre-specified Outcome Measures:

Title

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

Description

- Proportion (%) of adverse events (AEs) leading to permanent study drug discontinuation and unexpected serious AEs (SAEs) at 12 weeks

Time Frame

0-12 weeks

Title

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.

Description

- Rate (# of events per 100 person-years) of all-cause mortality (ACM)

Time Frame

0-12 weeks

Title

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.

Description

- Rate (# of events per 100 person-years) of MACE (3-point) = death due to any cause, MI, and/or stroke/TIA

Time Frame

0-12 weeks

Title

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.

Description

- Rate (# of events per 100 person-years) of MACE (4-point) = MACE (3-point) + hospitalization for unstable angina

Time Frame

0-12 weeks

Title

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.

Description

- Rate (# of events per 100 person-years) of MACE (5-point) = MACE (4-point) + any coronary revascularization

Time Frame

0-12 weeks

Title

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.

Description

- Rate (# of events per 100 person-years) of all-cause emergency department (ED) visits + all-cause hospitalizations

Time Frame

0-12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Andrew P Ambrosy, MD

Phone

415-271-9703

Andrew.P.Ambrosy@kp.org

First Name & Middle Initial & Last Name or Official Title & Degree

Alan S Go, MD

Phone

510-891-3422

Alan.S.Go@kp.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrew P Ambrosy, MD

Organizational Affiliation

Kaiser Permanente Northern California Division of Research

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Alan S Go, MD

Organizational Affiliation

Kaiser Permanente Northern California Division of Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kaiser Permanente Northern California Division of Research

City

Oakland

State/Province

California

ZIP/Postal Code

94612

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rachel C Thomas, RN

Phone

510-891-3858

Rachel.C.Thomas@kp.org

First Name & Middle Initial & Last Name & Degree

Andrew P Ambrosy, MD

First Name & Middle Initial & Last Name & Degree

Alan S Go, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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