Comparison of Two Lipid Management Strategies in Very High Risk Patients (PENELOPECTRL)

PENELOPE-CTRL: Real Life Lipid Management Compared to Protocolized Implementation of the Current Dutch- and ESC-guidelines in Very High-risk CV-patients

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Atherosclerotic Cardiovascular Disease; STEMI; Non STEMI

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 Type: Observational
• Enrollment (Anticipated): 700

Contacts and Locations

Study Locations

• Netherlands
  • Alkmaar, Netherlands
    • NoordWest Hospital (NWZ)
  • Delft, Netherlands
    • Reinier de Graaf Hospital
  • Den Haag, Netherlands
    • Haaglanden hospital
  • Den Haag, Netherlands
    • Haga Hospital
  • Deventer, Netherlands
    • Deventer Hospital
  • Emmen, Netherlands
    • Treant Hospital
  • Hardenberg, Netherlands
    • Saxenburg Medisch Centrum
  • Helmond, Netherlands
    • Elkerliek Hospital
  • Leiden, Netherlands
    • Alrijne Hospital
  • Meppel, Netherlands
    • Isala Hospital
  • Nijmegen, Netherlands
    • Canisius Wilhemina Hospital (CWZ)
  • Utrecht, Netherlands
    • Diakonessenhuis Utrecht
  • Veldhoven, Netherlands
    • Maxima Medisch Centrum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	1 year
LLT compared to PENELOPE cohort	Lipid lowering therapy at baseline, after 3 months and 1 year, compared to the designated PENELOPE cohort.	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.	3 months

Collaborators and Investigators

• Sponsor: Clinical Operations WCN B.V.
• Collaborators: Sanofi
• Investigators: Principal Investigator: Marco Alings, WCN

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2022
• Primary Completion (Actual): January 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: December 12, 2022
• First Submitted That Met QC Criteria: December 12, 2022
• First Posted (Actual): December 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 30, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Cardiovascular Diseases; Atherosclerosis
• Other Study ID Numbers: DCV-2017-11843

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No