NCT05659888

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
827

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 25, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 21, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

July 26, 2024

Status Verified

July 1, 2024

Enrollment Period

6 months

First QC Date

December 12, 2022

Last Update Submit

July 24, 2024

Conditions

Atherosclerotic Cardiovascular DiseaseSTEMINon STEMI

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

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

    1 year

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

    1 year

  • incidence of achieving 50% LDL-C reduction

    1 year

  • LLT compared to PENELOPE cohort

    1 year

  • LDL-C level 3 months after adjustment

    3 months

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

  • Pregnant and lactating women
  • Participation in lipid modifying drug trials up to two years after index cardiovascular event

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

NoordWest Hospital (NWZ)

Alkmaar, Netherlands

Location

Reinier de Graaf Hospital

Delft, Netherlands

Location

Deventer Hospital

Deventer, Netherlands

Location

Treant Hospital

Emmen, Netherlands

Location

Saxenburg Medisch Centrum

Hardenberg, Netherlands

Location

Elkerliek Hospital

Helmond, Netherlands

Location

Alrijne Hospital

Leiden, Netherlands

Location

Isala Hospital

Meppel, Netherlands

Location

Canisius Wilhemina Hospital (CWZ)

Nijmegen, Netherlands

Location

Haaglanden Hospital

The Hague, Netherlands

Location

Haga Hospital

The Hague, Netherlands

Location

Diakonessenhuis Utrecht

Utrecht, Netherlands

Location

Maxima Medisch Centrum

Veldhoven, Netherlands

Location

MeSH Terms

Conditions

AtherosclerosisST Elevation Myocardial InfarctionNon-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesMyocardial InfarctionMyocardial IschemiaHeart DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Marco Alings

    WCN

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
18 Months
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2022

First Posted

December 21, 2022

Study Start

July 25, 2022

Primary Completion

January 31, 2023

Study Completion

December 31, 2023

Last Updated

July 26, 2024

Record last verified: 2024-07

Locations

NL(13)