Real Life Lipid Management in Hospitals Not Participating in PENELOPE Trial - Control Population for PENELOPE

Completed

• Conditions: Atherosclerotic Cardiovascular Disease; STEMI; Non STEMI

• Registration Number: NCT05659888
• Lead Sponsor: Clinical Operations WCN B.V.

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.

Study Timeline

• Study Start: 2022-07-25
• Study First Submitted: 2022-12-12
• Study First Submitted QC: 2022-12-12
• Study First Posted: 2022-12-21
• Primary Completion: 2023-01-31
• Study Completion: 2023-12-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-24
• Last Update Posted: 2024-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 827

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients reaching the LDL-C target level (≤ 1.8 mmol/L)	3 months	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

Secondary Outcome Measures

Name	Time	Method
Incidence of LDL-C target level (≤ 1.4 mmol/L)	1 year	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.
LDL-C level 3 months after adjustment	3 months	LDL-C level at 3 months, also adjusted to the start date of the related drug regimen.
Incidence of LDL-C target level (≤ 1.8 mmol/L)	1 year	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.
LLT compared to PENELOPE cohort	1 year	Lipid lowering therapy at baseline, after 3 months and 1 year, compared to the designated PENELOPE cohort.
incidence of achieving 50% LDL-C reduction	1 year	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.

Trial Locations

Locations (13)

Reinier de Graaf Hospital; 🇳🇱 Delft, Netherlands

Haaglanden Hospital; 🇳🇱 Den Haag, Netherlands

Treant Hospital; 🇳🇱 Emmen, Netherlands

Elkerliek Hospital; 🇳🇱 Helmond, Netherlands

Alrijne Hospital; 🇳🇱 Leiden, Netherlands

Isala Hospital; 🇳🇱 Meppel, Netherlands

Canisius Wilhemina Hospital (CWZ); 🇳🇱 Nijmegen, Netherlands

Maxima Medisch Centrum; 🇳🇱 Veldhoven, Netherlands

Haga Hospital; 🇳🇱 Den Haag, Netherlands

Deventer Hospital; 🇳🇱 Deventer, Netherlands

NoordWest Hospital (NWZ); 🇳🇱 Alkmaar, Netherlands

Saxenburg Medisch Centrum; 🇳🇱 Hardenberg, Netherlands

Diakonessenhuis Utrecht; 🇳🇱 Utrecht, Netherlands