N/A N=9,559

Treatment of High and Very High riSk Dyslipidemic pAtients for the PreveNTion of CardiOvasculaR Events

Dyslipidemia · Cardiovascular Diseases · Hypercholesterolemia · Atherosclerotic Cardiovascular Disease

Bottom Line

View on ClinicalTrials.gov: NCT04271280 ↗

Enrolled (actual)

9,559

Serious AEs

—

Results posted

Feb 2024

Primary outcome: Primary: Mean Low Density Lipid-Cholesterol (LDL-C) Levels in High and Very High Risk Cardiovascular Participants — 2.40; 1.99 mmol/L

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Non-interventional (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Primary completion: Apr 2022

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	—

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.

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

View full record on ClinicalTrials.gov →

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.