Clinical trial

Non-Interventional Study On The Treatment With Bempedoic Acid And/Or Its Fixed-dose Combination With Ezetimibe in Routine Clinical Practice in Patients With Primary Hypercholesterolemia Or Mixed Dyslipidemia

Name
DSE-BMP-01-22-EU
Description
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 arms
Trial start
2023-09-01
Estimated PCD
2026-04-01
Trial end
2026-04-01
Status
Withdrawn
Treatment
Bempedoic acid and/or its fixed dose combination with ezetimibe
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.
Arms:
Bempedoic acid and/or fixed-dose combination with ezetimibe
Primary endpoint
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
Eligibility criteria
Inclusion Criteria: * Written informed consent to participate * At least 18 years of age * Participants suffering from documented primary hypercholesterolemia or mixed dyslipidemia * Part 1: For participants treated to a maximum of 6 months 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 participant in the study at the discretion of the physician under no reimbursement conditions at enrollment * Part 2: For 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 reimbursed conditions at enrollment * 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 Exclusion Criteria: * As this is a non-interventional study, no explicit exclusion criteria exist in order to avoid selection bias and to allow for documentation of routine clinical practice.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}
Updated at
2023-12-06

1 organization

1 product

2 indications

Indication
Dyslipidemia