Comparison of Two Lipid Management Strategies in Very High Risk Patients

STEMI Clinical Trial

— PENELOPECTRL  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05659888
• Other study ID #: DCV-2017-11843
• Status: Enrolling by invitation
• Start date: July 25, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2022
• Source: Clinical Operations WCN B.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 700
• Est. completion date: December 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerotic Cardiovascular Disease
• Cardiovascular Diseases
• Non STEMI
• STEMI

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Clinical Operations WCN B.V.	Sanofi

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	LLT compared to PENELOPE cohort	Lipid lowering therapy at baseline, after 3 months and 1 year, compared to the designated PENELOPE cohort.	1 year
Secondary	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