Cardiovascular DiseasesPhase 4NCT05263778
Cholesterol Lowering Via Bempedoic Acid/Ezetimibe, an ACL-Inhibiting Regimen in Acute Coronary Syndrome Study
A Phase 4 study testing Bempedoic Acid / Ezetimibe Oral Tablet in people with Cardiovascular Diseases and NSTEMI, run by Kaiser Permanente at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, NSTEMI, STEMI
- What is being tested?
- Bempedoic Acid / Ezetimibe Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2022to Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Northern California Division of Research
Oakland, California, 94612
Rachel C Thomas, RN, 510-891-3858, Rachel.C.Thomas@kp.org
Andrew P Ambrosy, MD
About this study
Official title: 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.
Read the 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
- Being tested
- Bempedoic Acid / Ezetimibe Oral Tablet, Placebo
- Medical subject headings
- Cardiovascular Diseases, Non-ST Elevated Myocardial Infarction, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bempedoic Acid / Ezetimibe Oral TabletDrug
Also called Nexlizet
Bempedoic acid 180 mg/ezetimibe 10 mg by mouth once daily for 12 weeks
PlaceboDrug
Matching placebo by mouth once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Bempedoic acid 180 mg/ezetimibe 10 mg Receives: Drug: Bempedoic Acid / Ezetimibe Oral Tablet |
| Placebo | Placebo comparator | Matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
- Percent (%) change from baseline to week 12 in high-density lipoprotein cholesterol (HDL-C)
Measured: 0-12 weeks
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
Measured: 0-12 weeks
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)
Measured: 0-12 weeks
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
Measured: 0-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study startMar 2022 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic randomized clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Esperion Therapeutics, Inc.
- Responsible party
- Sponsor
- Investigators
- Andrew P Ambrosy, MD, Principal investigator, Kaiser Permanente Northern California Division of ResearchAlan S Go, MD, Principal investigator, Kaiser Permanente Northern California Division of Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05263778
- Sponsor's protocol ID
- 1824539
- Status last verified
- Mar 2022
- First submitted
- 14 Feb 2022
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cholesterol Lowering Via Bempedoic Acid/Ezetimibe, an ACL-Inhibiting Regimen in Acute Coronary Syndrome (CLEAR ACS) Study
- ClinicalTrials.gov ID
- NCT05263778
- Acronym / sponsor ID
- 1824539
- Conditions
- Cardiovascular Diseases, NSTEMI, STEMI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Esperion Therapeutics, Inc.
- Study start
- Mar 2022 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 3 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Pragmatic randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Drug: Bempedoic Acid / Ezetimibe Oral TabletBempedoic acid 180 mg/ezetimibe 10 mg |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bempedoic Acid / Ezetimibe Oral TabletAlso: NexlizetBempedoic acid 180 mg/ezetimibe 10 mg by mouth once daily for 12 weeks | Drug | Intervention |
| PlaceboMatching placebo by mouth once daily for 12 weeks | Drug | Placebo |
Primary outcome
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
4 secondary outcomes
To determine the efficacy of BA/E vs. matching placebo on the lipid profile following a recent ACS event.
Time frame: 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
To determine the efficacy of BA/E vs. matching placebo on the lipid profile following a recent ACS event.
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew P Ambrosy, MD principal investigator
Kaiser Permanente Northern California Division of Research
Alan S Go, MD principal investigator
Kaiser Permanente Northern California Division of Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bempedoic Acid / Ezetimibe Oral Tablet in people with Cardiovascular Diseases and NSTEMI, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew P Ambrosy, MD (415-271-9703, Andrew.P.Ambrosy@kp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of BA/E vs. matching placebo on LDL-C level following a recent ACS event. (time frame: 0-12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2022.