nctId: NCT06262685 id: 2023-509418-12-00 briefTitle: Efficacy, Safety and Cost-efficacy of a Pre-emptive Genotyping Strategy in Patients Receiving Statins acronym: PREVESTATGx overallStatus: NOT_YET_RECRUITING date: 2024-03-04 date: 2025-02-10 date: 2025-03-04 date: 2024-02-16 date: 2024-02-16 name: Instituto de Investigación Hospital Universitario La Paz class: OTHER name: Instituto de Salud Carlos III briefSummary: This is a Phase IV multicentre adaptive single-blinded randomized clinical trial if preemptively genotyping populations at risk of cardiovascular disease susceptible of receiving high or moderate doses of statin therapy is efficacious, cost-efficacious, and feasible within the Spanish National Health System when compared to the current standard of care. This trial is nested within the iPHARMGx master protocol conditions: Cardiovascular Diseases conditions: Dyslipidemias conditions: Statin Adverse Reaction conditions: Pharmacogenic Myopathy studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Phase IV, multicentre, controlled, randomized, parallel and single-blind adaptive clinical trial nested within the iPHARMGx master protocol study primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Subjects will remain blinded to arm assigned because pharmacogenetic phenotype and statin/dose-guidance will only be exclusively accesible to the attending physician whoMasked: PARTICIPANT count: 216 type: ESTIMATED name: Preemptive pharmacogenetic atorvastatin dose based on CPIC guidelines name: Preemptive pharmacogenetic simvastatin dose based on CPIC guidelines name: Preemptive pharmacogenetic pitavastatin dose based on CPIC guidelines name: Preemptive pharmacogenetic rosuvastatin dose based on CPIC guidelines name: Preemptive pharmacogenetic pravastatin dose based on CPIC guidelines name: Preemptive pharmacogenetic lovastatin dose based on CPIC guidelines name: Preemptive pharmacogenetic fluvastatin dose based on CPIC guidelines name: Standard of Care (SoC) dosing of atorvastatin name: Standard of Care (SoC) dosing of simvastatin name: Standard of Care (SoC) dosing of pitavastatin name: Standard of Care (SoC) dosing of rosuvastatin name: Standard of Care (SoC) dosing of prasavastatin name: Standard of Care (SoC) dosing of lovastatin name: Standard of Care (SoC) dosing of fluvastatin measure: Incidence of clinically relevant statin-associated musculoskeletal events measure: Low density lipoprotein cholesterol (LDLc) serum concentration baseline reduction rate measure: Baseline change in statin therapy prescription measure: Cost of a statin preemptive pharmacogenetic prescription scheme measure: Novel prognostic and predictive genetic biomarkers of statin-related adverse events and efficacy identification measure: Death from cardiovascular causes, nonfatal myocardial infarction or hospitalization for unstable angina or resuscitated cardiac arrest measure: Difference in percentage in the eight-item Morisky Medication Adherence Scale (MMAS-8) questionnaire score between intervention and control arm measure: SAMS intensity reduction of a statin preemptive pharmacogenetic prescription scheme sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital La Paz city: Madrid state: Comunidad De Madrid zip: 28046 country: Spain name: Stefan Mark Stewart Balbás, MD role: CONTACT lat: 40.4165 lon: -3.70256 hasResults: False