Lipid-lowering Therapy Individualization

NCT ID: NCT03604471

Last Updated: 2019-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-08
• Study Completion Date: 2019-08-27

Brief Summary

This clinical study will explore individual factors influencing statin pharmacokinetics in a cohort of 150 patients treated with atorvastatin.

Detailed Description

Atorvastatin is widely prescribed for the treatment of hypercholesterolemia to prevent the risk of cardiovascular diseases, a leading death cause in industrialized countries. There exists considerable inter-individual variability in response to statins, reflected by differences in lipid-lowering effect or risk of presenting adverse drug reaction; mainly myotoxicity. A plethora of different factors (demographic, genetic, physiopathologic, environmental...) have been tested to explain this variability but it lacks of pharmacokinetic (PK) data and/or replications of observations are rare and results remain inconclusive, probably because of non-adapted designs and no-clear driven-hypothesis but also due to a lack of scientific rationale and deep mechanistic understanding. This clinical study will explore individual factors influencing statin PK in a cohort of 150 patients treated with atorvastatin. The collection of meticulous clinical PK data and a rigorous statistical analysis will allow quantifying the effect of each identified parameter on statin PK and eventually, defining a population-based PK model taking into account the combined effect of all covariates in a quantitative approach. This innovative prospectively designed clinical study will ultimately allow predicting atorvastatin PK fluctuations and anticipating any inadequate dosing in clinical care.

Conditions

Hypercholesterolemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Atorvastatin

All patients using atorvastatin at any dose (usually ranging from 5 to 80 mg once-daily).

Group Type: OTHER

Atorvastatin

Intervention Type: DRUG

Blood sampling for atorvastatin quantification and pharmacogenetic analysis.

Interventions

Atorvastatin

Blood sampling for atorvastatin quantification and pharmacogenetic analysis.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Treatment with atorvastatin (any dose)

Exclusion Criteria

• Unable to provide informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role: collaborator

Université Catholique de Louvain

OTHER

Sponsor Role: lead

Responsible Party

Laure Elens

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jean-Luc Balligand, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Locations

Cliniques universitaires Saint-Luc

Brussels, , Belgium

Countries

Belgium

Other Identifiers

2016/26OCT/471

Identifier Type: -

Identifier Source: org_study_id