NCT05798390

Brief Summary

Cardiovascular disease (CVD), especially its management and associated costs, remains a major concern globally. There is a direct correlation between circulating levels of low-density lipoprotein cholesterol (LDL-C) and the incidence of CVD. This study will assess bempedoic acid/FDC in a real-world clinical setting in adult patients in Spain with hypercholesterolaemia or mixed dyslipidemia.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2023

Typical duration for all trials

Status
withdrawn

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

First Submitted

Initial submission to the registry

March 10, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 4, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

December 6, 2023

Status Verified

November 1, 2023

Enrollment Period

2.6 years

First QC Date

March 10, 2023

Last Update Submit

November 29, 2023

Conditions

Primary HypercholesterolemiaMixed Dyslipidemia

Keywords

Primary HypercholesterolemiaMixed DyslipidemiaBempedoic acid and/or its fixed-dose combination with ezetimibe

Outcome Measures

Primary Outcomes (1)

  • Summary of Patient Characteristics in Participants With Primary Hypercholesterolaemia or Mixed Dyslipidaemia Following Treatment With Bempedoic Acid And/Or Its Fixed-dose Combination With Ezetimibe

    Baseline up to 12 months

Secondary Outcomes (17)

  • Mean Change From Baseline in Systematic Coronary Risk Estimation (SCORE) System Following Treatment With Bempedoic Acid And/Or Its Fixed-dose Combination With Ezetimibe

    Baseline up to 12 months

  • Mean Change From Baseline in Second Manifestations of Arterial Disease (SMART) Score Following Treatment With Bempedoic Acid And/Or Its Fixed-dose Combination With Ezetimibe

    Baseline up to 12 months

  • Mean Change From Baseline in Framingham Risk Score Following Treatment With Bempedoic Acid And/Or Its Fixed-dose Combination With Ezetimibe

    Baseline up to 12 months

  • Mean Change From Baseline in Low-density Lipoprotein Cholesterol Levels

    Baseline up to 12 months

  • Mean Change From Baseline in Atherosclerotic Cardiovascular Disease-Modifying Cholesterol Fragments Levels

    Baseline up to 12 months

  • +12 more secondary outcomes

Study Arms (1)

Bempedoic acid and/or fixed-dose combination with ezetimibe

Participants with primary hypercholesterolemia or mixed dyslipidemia who received bempedoic acid and/or its fixed-dose combination with ezetimibe.

Drug: Bempedoic acid and/or its fixed dose combination with ezetimibe

Interventions

Bempedoic acid and/or its fixed dose combination with ezetimibeDRUG

This is a non-interventional study. No study medication will be provided as part of this protocol to the patients. Medications will be as prescribed by the treating physician in line with clinical practice.

Bempedoic acid and/or fixed-dose combination with ezetimibe

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of participants treated or intended to be treated with bempedoic acid/ FDC under usual clinical practice conditions and as long as the decision of the physician to start treatment is prior to the inclusion of the patient in the study under no reimbursement conditions (Part 1) or under reimbursed conditions (Part 2) at enrollment and who are unable to reach their LDL-C goals with the maximum tolerated dose of statins or patients who are determined by their treating physician to be statin intolerant.

You may qualify if:

  • Written informed consent to participate
  • At least 18 years of age
  • Participants suffering from documented primary hypercholesterolemia or mixed dyslipidemia
  • No contraindications exist according to the SmPC of bempedoic acid/ FDC
  • No concurrent participation in an interventional study (Simultaneous participation in other non-interventional studies is possible)
  • Life expectancy \> 1 -year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Ezetimibe

Intervention Hierarchy (Ancestors)

AzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Global Clinical Leader

    Daiichi Sankyo

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2023

First Posted

April 4, 2023

Study Start

September 1, 2023

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

December 6, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share