N/A
Completed N=9,559
Treatment of High and Very High riSk Dyslipidemic pAtients for the PreveNTion of CardiOvasculaR Events
Source: ClinicalTrials.gov NCT04271280 ↗Enrolled (actual)
9,559
Serious AEs
—
Results posted
Feb 2024
Primary outcomePrimary: Mean Low Density Lipid-Cholesterol (LDL-C) Levels in High and Very High Risk Cardiovascular Participants — 2.40; 1.99 mmol/L
Summary
High and Very High Risk cardiovascular patient journeys seems to vary from country to country, and current understanding of the process is incomplete. This real-life observational study which documents meaningful patient journey-related parameters can be expected to provide meaningful insight into the care process, country-by-country.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Low Density Lipid-Cholesterol (LDL-C) Levels in High and Very High Risk Cardiovascular Participants |
2.40; 1.99 | — |
| PRIMARY Number of Participants Utilizing Any Treatment Modality to Manage Plasma Levels of Low Density Lipid-Cholesterol (LDL-C) in High and Very High Risk Participants Requiring Lipid Modifying Therapies (LMTs) |
8931; 7680; 2538; 2128 | — |
| SECONDARY Mean Atherosclerotic Cardiovascular Disease (ASCVD)-Modifying Cholesterol Fragment Levels in High Risk and Very High Risk Dyslipidemic Participants |
1.27; 1.28; 3.02; 2.58; 4.31; 3.86 | — |
| SECONDARY Mean Apolipoprotein B Levels in High Risk and Very High Risk Dyslipidemic Participants |
0.92; 0.80 | — |
| SECONDARY Mean Lipid Protein A Levels in High Risk and Very High Risk Dyslipidemic Participants |
47.97; 51.24 | — |
| SECONDARY Mean Inflammatory High-Sensitive C-Reactive Protein (hsCRP) in High Risk and Very High Risk Dyslipidemic Participants |
6.90; 4.3 | — |
| SECONDARY Number of Participants With Clinical Events Associated With Treatment Modalities, For Any LMT |
423; 338; 2; 19; 8; 59 | — |
Eligibility Criteria
Inclusion Criteria
- Very High Risk and High Risk dyslipidemic patients requiring LMTs
- Not simultaneously participating in any interventional study
- Providing written informed consent for participation in the study (Informed consent form)
- Life expectancy > 1 year
Exclusion Criteria
- Not applicable; non-interventional study
Data sourced from ClinicalTrials.gov (NCT04271280). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.