Real Life Lipid Management in Hospitals Not Participating in PENELOPE Trial - Control Population for PENELOPE
NCT ID: NCT05659888
Last Updated: 2024-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
827 participants
OBSERVATIONAL
2022-07-25
2023-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
OTHER
Eligibility Criteria
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Inclusion Criteria
* 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
* Participation in lipid modifying drug trials up to two years after index cardiovascular event
18 Years
70 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Clinical Operations WCN B.V.
NETWORK
Responsible Party
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Principal Investigators
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Marco Alings
Role: PRINCIPAL_INVESTIGATOR
WCN
Locations
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NoordWest Hospital (NWZ)
Alkmaar, , Netherlands
Reinier de Graaf Hospital
Delft, , 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
Haaglanden Hospital
The Hague, , Netherlands
Haga Hospital
The Hague, , Netherlands
Diakonessenhuis Utrecht
Utrecht, , Netherlands
Maxima Medisch Centrum
Veldhoven, , Netherlands
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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DCV-2017-11843
Identifier Type: -
Identifier Source: org_study_id
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