Status:
UNKNOWN
Cholesterol Lowering Via Bempedoic Acid/Ezetimibe, an ACL-Inhibiting Regimen in Acute Coronary Syndrome Study
Lead Sponsor:
Kaiser Permanente
Collaborating Sponsors:
Esperion Therapeutics, Inc.
Conditions:
Cardiovascular Diseases
NSTEMI
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 tol...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT05263778
Start Date
March 1 2022
End Date
December 1 2023
Last Update
March 3 2022
Active Locations (1)
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1
Kaiser Permanente Northern California Division of Research
Oakland, California, United States, 94612