protocolSection identificationModule nctId: NCT06262685, orgStudyIdInfo id: 2023-509418-12-00, briefTitle: Efficacy, Safety and Cost-efficacy of a Pre-emptive Genotyping Strategy in Patients Receiving Statins, acronym: PREVESTATGx, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2025-02-10, completionDateStruct date: 2025-03-04, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Instituto de Investigación Hospital Universitario La Paz, class: OTHER, collaborators name: Instituto de Salud Carlos III, descriptionModule 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, conditionsModule conditions: Cardiovascular Diseases, conditions: Dyslipidemias, conditions: Statin Adverse Reaction, conditions: Pharmacogenic Myopathy, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo 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, maskingInfo 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, enrollmentInfo count: 216, type: ESTIMATED, armsInterventionsModule interventions name: Preemptive pharmacogenetic atorvastatin dose based on CPIC guidelines, interventions name: Preemptive pharmacogenetic simvastatin dose based on CPIC guidelines, interventions name: Preemptive pharmacogenetic pitavastatin dose based on CPIC guidelines, interventions name: Preemptive pharmacogenetic rosuvastatin dose based on CPIC guidelines, interventions name: Preemptive pharmacogenetic pravastatin dose based on CPIC guidelines, interventions name: Preemptive pharmacogenetic lovastatin dose based on CPIC guidelines, interventions name: Preemptive pharmacogenetic fluvastatin dose based on CPIC guidelines, interventions name: Standard of Care (SoC) dosing of atorvastatin, interventions name: Standard of Care (SoC) dosing of simvastatin, interventions name: Standard of Care (SoC) dosing of pitavastatin, interventions name: Standard of Care (SoC) dosing of rosuvastatin, interventions name: Standard of Care (SoC) dosing of prasavastatin, interventions name: Standard of Care (SoC) dosing of lovastatin, interventions name: Standard of Care (SoC) dosing of fluvastatin, outcomesModule primaryOutcomes measure: Incidence of clinically relevant statin-associated musculoskeletal events, secondaryOutcomes measure: Low density lipoprotein cholesterol (LDLc) serum concentration baseline reduction rate, secondaryOutcomes measure: Baseline change in statin therapy prescription, secondaryOutcomes measure: Cost of a statin preemptive pharmacogenetic prescription scheme, otherOutcomes measure: Novel prognostic and predictive genetic biomarkers of statin-related adverse events and efficacy identification, otherOutcomes measure: Death from cardiovascular causes, nonfatal myocardial infarction or hospitalization for unstable angina or resuscitated cardiac arrest, otherOutcomes measure: Difference in percentage in the eight-item Morisky Medication Adherence Scale (MMAS-8) questionnaire score between intervention and control arm, otherOutcomes measure: SAMS intensity reduction of a statin preemptive pharmacogenetic prescription scheme, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital La Paz, city: Madrid, state: Comunidad De Madrid, zip: 28046, country: Spain, contacts name: Stefan Mark Stewart Balbás, MD, role: CONTACT, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False