Ignite Creation Date:
2024-05-06 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05263778
Status:
UNKNOWN
Last Update Posted:
2022-03-03
First Post:
2022-02-14
Brief Title:
Cholesterol Lowering Via Bempedoic AcidEzetimibe an ACL-Inhibiting Regimen in Acute Coronary Syndrome Study
Sponsor:
Kaiser Permanente
Organization:
Kaiser Permanente
Study Overview
Official Title:
Cholesterol Lowering Via Bempedoic AcidEzetimibe an ACL-Inhibiting Regimen in Acute Coronary Syndrome CLEAR ACS Study
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overall objective of the Cholesterol Lowering via Bempedoic AcidEzetimibe an ACL-Inhibiting Regimen in Acute Coronary Syndrome ACS CLEAR ACS study is to determine the efficacy safety and tolerability of bempedoic acidezetimibe BAE in a contemporary and real-world population enriched for older adults women and underrepresented racialethnic 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 Californias 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 11 allocation ratio to an initial 12 weeks of blinded bempedoic acidezetimibe BAE vs matching placebo followed by a 12-week open-label extension phase where all patients will receive open-label unblinded bempedoic acidezetimibe
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None