Atherosclerotic Cardiovascular DiseasePENELOPECTRLNCT05659888
Real Life Lipid Management in Hospitals Not Participating in PENELOPE Trial - Control Population for PENELOPE
An observational study of Atherosclerotic Cardiovascular Disease and STEMI, run by Clinical Operations WCN B.V. at 13 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atherosclerotic Cardiovascular Disease, STEMI, Non STEMI
- How many people
- 827 participants
- Where
- 13 sitesNetherlands
- Study dates
- 25 Jul 2022to 31 Dec 2023
- How long will I take part?
- 18 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- Pregnant and lactating women
- Participation in lipid modifying drug trials up to two years after index cardiovascular event
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Netherlands13 sites
NoordWest Hospital (NWZ)
Alkmaar
Reinier de Graaf Hospital
Delft
Deventer Hospital
Deventer
Treant Hospital
Emmen
Saxenburg Medisch Centrum
Hardenberg
Elkerliek Hospital
Helmond
Alrijne Hospital
Leiden
Isala Hospital
Meppel
Canisius Wilhemina Hospital (CWZ)
Nijmegen
Haaglanden Hospital
The Hague
Haga Hospital
The Hague
Diakonessenhuis Utrecht
Utrecht
Maxima Medisch Centrum
Veldhoven
About this study
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
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.
Read the 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.
- Conditions
- Atherosclerotic Cardiovascular Disease, STEMI, Non STEMI
- Medical subject headings
- Atherosclerosis, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 1 year
LLT compared to PENELOPE cohort
Lipid lowering therapy at baseline, after 3 months and 1 year, compared to the designated PENELOPE cohort.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start25 Jul 2022
- Primary completion31 Jan 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 827 participants (actual)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Clinical Operations WCN B.V.
- Sponsor type
- Research network
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Marco Alings, Principal investigator, WCN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659888
- Sponsor's protocol ID
- DCV-2017-11843
- Acronym
- PENELOPECTRL
- Status last verified
- Jul 2024
- First submitted
- 12 Dec 2022
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05659888
- Acronym / sponsor ID
- PENELOPECTRL / DCV-2017-11843
- Conditions
- Atherosclerotic Cardiovascular Disease, STEMI, Non STEMI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 827 participants (actual)
- Lead sponsor
- Clinical Operations WCN B.V.Research network
- Collaborators
- Sanofi
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 18 Months
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (2 listed)
- Pregnant and lactating women
- Participation in lipid modifying drug trials up to two years after index cardiovascular event
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
Incidence of LDL-C target level (≤ 1.8 mmol/L)
Time frame: 1 year
Incidence of LDL-C target level (≤ 1.4 mmol/L)
Time frame: 1 year
incidence of achieving 50% LDL-C reduction
Time frame: 1 year
LLT compared to PENELOPE cohort
Time frame: 1 year
LDL-C level 3 months after adjustment
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Alings principal investigator
WCN
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerotic Cardiovascular Disease and STEMI, run by Clinical Operations WCN B.V. at 13 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients reaching the LDL-C target level (≤ 1.8 mmol/L) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.