Clinical trial NCT05659888: Real Life Lipid Management in Hospitals Not Participating in PENELOPE Trial - Control Population for PENELOPE
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerotic Cardiovascular Disease
STEMI
Non STEMI
Lead sponsor: Clinical Operations WCN B.V.
Sponsor class: NETWORK
Collaborators: name: Sanofi
First posted: 2022-12-21
Enrollment: 827
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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 (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.

Eligibility criteria: Inclusion Criteria:

* Age \>18 and ≤70 years
* Alive at hospital discharge after admission for (N)STEMI between 1-1-2019 and 31-08-2020
* Planned for follow-up at a participating PENELOPE CTRL site
* History of T2DM and/or history of ASCVD defined as either one of:

  * cerebrovascular disease/ event: transient ischemic attack, cerebral infarction, amaurosis fugax, retinal infarction
  * Coronary artery disease/ event: unstable angina pectoris, MI, ACS, coronary revascularization (coronary angioplasty or surgical procedure for coronary bypass)
  * Peripheral artery disease (symptomatic and documented obstruction of a distal extremity artery or surgical intervention (percutaneous transluminal angioplasty, bypass or amputation)

Exclusion Criteria:

* Pregnant and lactating women
* Participation in lipid modifying drug trials up to two years after index cardiovascular event

Primary outcomes:
measure: Number of patients reaching the LDL-C target level (≤ 1.8 mmol/L)
timeFrame: 3 months
Secondary outcomes:
measure: Incidence of LDL-C target level (≤ 1.8 mmol/L)
timeFrame: 1 year
measure: Incidence of LDL-C target level (≤ 1.4 mmol/L)
timeFrame: 1 year
measure: incidence of achieving 50% LDL-C reduction
timeFrame: 1 year
measure: LLT compared to PENELOPE cohort
timeFrame: 1 year
measure: LDL-C level 3 months after adjustment
timeFrame: 3 months
Other outcomes:
Locations:
city: Alkmaar
country: Netherlands
facility: NoordWest Hospital (NWZ)
city: Delft
country: Netherlands
facility: Reinier de Graaf Hospital
city: Den Haag
country: Netherlands
facility: Haaglanden Hospital
city: Den Haag
country: Netherlands
facility: Haga Hospital
city: Deventer
country: Netherlands
facility: Deventer Hospital
city: Emmen
country: Netherlands
facility: Treant Hospital
city: Hardenberg
country: Netherlands
facility: Saxenburg Medisch Centrum
city: Helmond
country: Netherlands
facility: Elkerliek Hospital
city: Leiden
country: Netherlands
facility: Alrijne Hospital
city: Meppel
country: Netherlands
facility: Isala Hospital
city: Nijmegen
country: Netherlands
facility: Canisius Wilhemina Hospital (CWZ)
city: Utrecht
country: Netherlands
facility: Diakonessenhuis Utrecht
city: Veldhoven
country: Netherlands
facility: Maxima Medisch Centrum
Study officials:
affiliation: WCN
name: Marco Alings
role: PRINCIPAL_INVESTIGATOR
References: