Ignite Creation Date:
2024-05-06 @ 6:25 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05659888
Status:
COMPLETED
Last Update Posted:
2023-03-30
First Post:
2022-12-12
Brief Title:
Real Life Lipid Management in Hospitals Not Participating in PENELOPE Trial - Control Population for PENELOPE
Sponsor:
Clinical Operations WCN BV
Organization:
Clinical Operations WCN BV
Study Overview
Official Title:
PENELOPE-CTRL Real Life Lipid Management Compared to Protocolized Implementation of the Current Dutch- and ESC-guidelines in Very High-risk CV-patients
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
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:
PENELOPECTRL
Brief Summary:
Guideline recommended evidence-based clinical care correlates with improved patient outcomes In real life care however adherence to guideline recommendations remains suboptimal In real life patients may receive suboptimal treatment and as a result treatment targets are not always met To support and improve secondary prevention for cardiovascular disease PENELOPE and PENELOPE-CTRL are designed to support guideline implementation on lipid management and provide valuable feedback to care-givers on real world data
Detailed Description:
The recent PENELOPE study was designed to determine the effect of a protocolized Dutch- and ESC- guideline based strategy of stepwise intensified lipid management in patients at very high risk for ACS In PENELOPE 22 Dutch non-academic hospitals members of the WCN investigator network implemented a protocol guided guideline approach in a consecutive cohort of very high-risk patients admitted for ACS over the period 01-01-2019 to 31-08-2020 Lipid values and medication strategy are collected at baseline index ACS and after three months and one year post ACS in order to establish the percentage of patients on target LDL
The current PENELOPE-CTRL study on the other hand is designed to serve as a contemporary control cohort for PENELOPE PENELOPE-CTRL is a retrospective observational study creating a contemporary snapshot of real-life lipid management for secondary prevention in very high-risk patients PENELOPE-CTRL will collect data in similar hospitals who did not participate in the PENELOPE trial
To allow comparison of these two strategies protocol guided versus real life implementation of the cholesterol treatment guidelines both cohorts include similar patients and similar data will be collected eg lipid lowering drugs lipid panels Analysis will be done at similar time points
Comparing the real-life data from PENELOPE-CTRL with the data from the PENELOPE study will quantify the effect of a strategy of protocolized guideline-based lipid management with regards to the incidence of target LDL-C levels in very high-risk patients 3 months and one year after hospitalisation with a myocardial infarction
The current PENELOPE-CTRL study on the other hand is designed to serve as a contemporary control cohort for PENELOPE PENELOPE-CTRL is a retrospective observational study creating a contemporary snapshot of real-life lipid management for secondary prevention in very high-risk patients PENELOPE-CTRL will collect data in similar hospitals who did not participate in the PENELOPE trial
To allow comparison of these two strategies protocol guided versus real life implementation of the cholesterol treatment guidelines both cohorts include similar patients and similar data will be collected eg lipid lowering drugs lipid panels Analysis will be done at similar time points
Comparing the real-life data from PENELOPE-CTRL with the data from the PENELOPE study will quantify the effect of a strategy of protocolized guideline-based lipid management with regards to the incidence of target LDL-C levels in very high-risk patients 3 months and one year after hospitalisation with a myocardial infarction
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None