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

March 1, 2022 updated by: Kaiser Permanente

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Oakland, California, United States, 94612
        • Kaiser Permanente Northern California Division of Research
        • Contact:
        • Principal Investigator:
          • Andrew P Ambrosy, MD
        • Principal Investigator:
          • Alan S Go, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Matching placebo
Drug: Placebo
Matching placebo by mouth once daily for 12 weeks
Active Comparator: Intervention
Bempedoic acid 180 mg/ezetimibe 10 mg
Drug: Bempedoic Acid / Ezetimibe Oral Tablet
Bempedoic acid 180 mg/ezetimibe 10 mg by mouth once daily for 12 weeks
Other Names:
  • Nexlizet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To evaluate the efficacy of BA/E vs. matching placebo on LDL-C level following a recent ACS event.
Time Frame: 0-12 weeks
Percent (%) change from baseline to week 12 in LDL-C level
0-12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To determine the efficacy of BA/E vs. matching placebo on the lipid profile following a recent ACS event.
Time Frame: 0-12 weeks
- Percent (%) change from baseline to week 12 in high-density lipoprotein cholesterol (HDL-C)
0-12 weeks
To determine the efficacy of BA/E vs. matching placebo on the lipid profile following a recent ACS event.
Time Frame: 0-12 weeks
- Percent (%) change from baseline to week 12 in non-HDL-C
0-12 weeks
To determine the efficacy of BA/E vs. matching placebo on the lipid profile following a recent ACS event.
Time Frame: 0-12 weeks
- Percent (%) change from baseline to week 12 in total cholesterol (TC)
0-12 weeks
To determine the efficacy of BA/E vs. matching placebo on the lipid profile following a recent ACS event.
Time Frame: 0-12 weeks
- Percent (%) change from baseline to week 12 in triglyceride (TGs) levels
0-12 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To assess the safety and tolerability of BA/E vs. matching placebo following a recent ACS event.
Time Frame: 0-12 weeks
- Proportion (%) of adverse events (AEs) leading to permanent study drug discontinuation and unexpected serious AEs (SAEs) at 12 weeks
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.
Time Frame: 0-12 weeks
- Rate (# of events per 100 person-years) of all-cause mortality (ACM)
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.
Time Frame: 0-12 weeks
- Rate (# of events per 100 person-years) of MACE (3-point) = death due to any cause, MI, and/or stroke/TIA
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.
Time Frame: 0-12 weeks
- Rate (# of events per 100 person-years) of MACE (4-point) = MACE (3-point) + hospitalization for unstable angina
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.
Time Frame: 0-12 weeks
- Rate (# of events per 100 person-years) of MACE (5-point) = MACE (4-point) + any coronary revascularization
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.
Time Frame: 0-12 weeks
- Rate (# of events per 100 person-years) of all-cause emergency department (ED) visits + all-cause hospitalizations
0-12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kaiser Permanente

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Esperion Therapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andrew P Ambrosy, MD, Kaiser Permanente Northern California Division of Research
  • Principal Investigator: Alan S Go, MD, Kaiser Permanente Northern California Division of Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1824539

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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