Efficacy, Safety and Cost-efficacy of a Pre-emptive Genotyping Strategy in Patients Receiving Statins

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

216

Participants

Timeline

Start Date

March 4, 2024

Primary Completion Date

February 10, 2025

Study Completion Date

March 4, 2025

Conditions
Cardiovascular DiseasesDyslipidemiasStatin Adverse ReactionPharmacogenic Myopathy
Interventions
OTHER

Preemptive pharmacogenetic atorvastatin dose based on CPIC guidelines

"Atorvastatin at the dosage reccomended by the 2022 Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for SLCO1B1, ABCG2, and CYP2C9 genotypes and considerations for Statin-Associated Musculoskeletal Symptoms based on the subjects pharmacogenetic phenotype. A comprehensive description of said doses are can be accessed at: https://cpicpgx.org/guidelines/cpic-guideline-for-statins/"

OTHER

Preemptive pharmacogenetic simvastatin dose based on CPIC guidelines

"Simvastatin at the dosage reccomended by the 2022 Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for SLCO1B1, ABCG2, and CYP2C9 genotypes and considerations for Statin-Associated Musculoskeletal Symptoms based on the subjects pharmacogenetic phenotype. A comprehensive description of said doses are can be accessed at: https://cpicpgx.org/guidelines/cpic-guideline-for-statins/"

OTHER

Preemptive pharmacogenetic pitavastatin dose based on CPIC guidelines

"Pitavastatin at the dosage reccomended by the 2022 Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for SLCO1B1, ABCG2, and CYP2C9 genotypes and considerations for Statin-Associated Musculoskeletal Symptoms based on the subjects pharmacogenetic phenotype. A comprehensive description of said doses are can be accessed at: https://cpicpgx.org/guidelines/cpic-guideline-for-statins/"

OTHER

Preemptive pharmacogenetic rosuvastatin dose based on CPIC guidelines

"Rosuvastatin at the dosage reccomended by the 2022 Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for SLCO1B1, ABCG2, and CYP2C9 genotypes and considerations for Statin-Associated Musculoskeletal Symptoms based on the subjects pharmacogenetic phenotype. A comprehensive description of said doses are can be accessed at: https://cpicpgx.org/guidelines/cpic-guideline-for-statins/"

OTHER

Preemptive pharmacogenetic pravastatin dose based on CPIC guidelines

"Pravastatin at the dosage reccomended by the 2022 Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for SLCO1B1, ABCG2, and CYP2C9 genotypes and considerations for Statin-Associated Musculoskeletal Symptoms based on the subjects pharmacogenetic phenotype. A comprehensive description of said doses are can be accessed at: https://cpicpgx.org/guidelines/cpic-guideline-for-statins/"

OTHER

Preemptive pharmacogenetic lovastatin dose based on CPIC guidelines

"Lovastatin at the dosage reccomended by the 2022 Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for SLCO1B1, ABCG2, and CYP2C9 genotypes and considerations for Statin-Associated Musculoskeletal Symptoms based on the subjects pharmacogenetic phenotype. A comprehensive description of said doses are can be accessed at: https://cpicpgx.org/guidelines/cpic-guideline-for-statins/"

OTHER

Preemptive pharmacogenetic fluvastatin dose based on CPIC guidelines

"Fluvastatin at the dosage reccomended by the 2022 Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for SLCO1B1, ABCG2, and CYP2C9 genotypes and considerations for Statin-Associated Musculoskeletal Symptoms based on the subjects pharmacogenetic phenotype. A comprehensive description of said doses are can be accessed at: https://cpicpgx.org/guidelines/cpic-guideline-for-statins/"

OTHER

Standard of Care (SoC) dosing of atorvastatin

Subject allocated to this arm will receive the atorvastatin according to clinical practice and the drug's product labelling, and never exceeding the already authorized dosages. These subject will not receive a personalised dosed/prescription based on their pharmacogenetic phenotype

OTHER

Standard of Care (SoC) dosing of simvastatin

Subject allocated to this arm will receive the simvastatin according to clinical practice and the drug's product labelling, and never exceeding the already authorized dosages. These subject will not receive a personalised dosed/prescription based on their pharmacogenetic phenotype

OTHER

Standard of Care (SoC) dosing of pitavastatin

Subject allocated to this arm will receive the pitavastatin according to clinical practice and the drug's product labelling, and never exceeding the already authorized dosages. These subject will not receive a personalised dosed/prescription based on their pharmacogenetic phenotype

OTHER

Standard of Care (SoC) dosing of rosuvastatin

Subject allocated to this arm will receive the rosuvastatin according to clinical practice and the drug's product labelling, and never exceeding the already authorized dosages. These subject will not receive a personalised dosed/prescription based on their pharmacogenetic phenotype

OTHER

Standard of Care (SoC) dosing of prasavastatin

Subject allocated to this arm will receive the prasavastatin according to clinical practice and the drug's product labelling, and never exceeding the already authorized dosages. These subject will not receive a personalised dosed/prescription based on their pharmacogenetic phenotype.

OTHER

Standard of Care (SoC) dosing of lovastatin

Subject allocated to this arm will receive the lovastatin according to clinical practice and the drug's product labelling, and never exceeding the already authorized dosages. These subject will not receive a personalised dosed/prescription based on their pharmacogenetic phenotype.

OTHER

Standard of Care (SoC) dosing of fluvastatin

Subject allocated to this arm will receive the fluvastatin according to clinical practice and the drug's product labelling, and never exceeding the already authorized dosages. These subject will not receive a personalised dosed/prescription based on their pharmacogenetic phenotype.

Trial Locations (1)

28046

Hospital La Paz, Madrid

All Listed Sponsors
collaborator

Instituto de Salud Carlos III

OTHER_GOV

lead

Instituto de Investigación Hospital Universitario La Paz

OTHER