An observational study in Atherosclerotic Cardiovascular Disease, STEMI and Non STEMI, sponsored by Clinical Operations WCN B.V.. Completed at 13 sites in Netherlands. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-07-26.
Sponsored by Clinical Operations WCN B.V. · Observational
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.
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 (e.g., 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.
1,596 studies on the registry are indexed under Atherosclerosis; 262 are open to participants now.
This study's enrollment of 827 is above the median of 230 across 581 observational studies indexed under Atherosclerosis.
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Patients with a history of ASCVD and/or type 2 diabetes (T2DM), admitted for a type I ST-elevation myocardial infarct (STEMI) or non-STEMI. Patients \<18 years or >70 years of age will be excluded.
In PENELOPE patients over 70 were included based on a frailty index. As this parameter cannot be determined retrospectively, patients over 70 will be excluded from the CTRL cohort, as well as from the comparative analysis for the two cohorts.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
History of T2DM and/or history of ASCVD defined as either one of:
Exclusion Criteria:
Number of patients reaching the LDL-C target level (≤ 1.8 mmol/L)
reaching LDL-C target level (≤ 1.8 mmol/L) 3 months after admission for a type I (N)STEMI, compared to the designated PENELOPE cohort
Time frame: 3 months
Incidence of LDL-C target level (≤ 1.8 mmol/L)
Incidence of LDL-C (≤ 1.8 mmol/L) at baseline (admission for a type I (N)STEMI), 3 months and 1 year after baseline, compared to the designated PENELOPE cohort.
Time frame: 1 year
Incidence of LDL-C target level (≤ 1.4 mmol/L)
Incidence of LDL-C (≤ 1.4 mmol/L) at baseline (admission for a type I (N)STEMI), 3 months and 1 year after baseline, compared to the designated PENELOPE cohort.
Time frame: 1 year
incidence of achieving 50% LDL-C reduction
Incidence of achieving 50% LDL-C reduction compared to baseline, after 3 months and 1 year, also adjusted to the start date of the related drug regimen.
Time frame: 1 year
LLT compared to PENELOPE cohort
Lipid lowering therapy at baseline, after 3 months and 1 year, compared to the designated PENELOPE cohort.
Time frame: 1 year
LDL-C level 3 months after adjustment
LDL-C level at 3 months, also adjusted to the start date of the related drug regimen.
Time frame: 3 months
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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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