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Completed

NCT Number: NCT05659888

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

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.

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Key information

Conditions

Atherosclerotic Cardiovascular Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Non STEMI Non-ST Elevated Myocardial Infarction Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction STEMI Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

NoordWest Hospital (NWZ), Alkmaar, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of patients reaching the LDL-C target level (≤ 1.8 mmol/L)

    Time frame: 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 outcomes

  1. Incidence of LDL-C target level (≤ 1.8 mmol/L)

    Time frame: 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.

  2. Incidence of LDL-C target level (≤ 1.4 mmol/L)

    Time frame: 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.

  3. incidence of achieving 50% LDL-C reduction

    Time frame: 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.

  4. LLT compared to PENELOPE cohort

    Time frame: 1 year

    Lipid lowering therapy at baseline, after 3 months and 1 year, compared to the designated PENELOPE cohort.

  5. LDL-C level 3 months after adjustment

    Time frame: 3 months

    LDL-C level at 3 months, also adjusted to the start date of the related drug regimen.

Sponsors and collaborators

Lead sponsor

Clinical Operations WCN B.V.

Network

Collaborators

  • Sanofi

Registry information

Official study title

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

Acronym: PENELOPECTRL

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 21, 2022
Registry last updated
Jul 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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