A multicentre controlled, randomised, single-blind adaptive phase IV protocol to evaluate efficacy, safety and cost-efficacy of pre-emptive genotyping strategy in a population at risk of cardiovascular disease susceptible of receiving high or moderate-intensity doses of statins - PREVESTATGx

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Patients at risk of cardiovascular disease susceptible of receiving high or moderate-intensity doses of statins.
Sponsor: Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Enrollment: 216
Status: Active, not recruiting
Last Updated: last year

No summary available.

Registry

who.int

Start Date

February 22, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Ability of the participant to understand the purpose and risks of the study, to provide informed consent, and to authorize the use of confidential health information in accordance with national and local privacy regulations., Subject has voluntarily signed the ICF., Subject must be \= 18 years old at the time of signing ICF., Subject is able and willing to take part and be followed\-up for the majority of the study duration., Participants are susceptible to be prescribed any of the following: a.Atorvastatin \=40 mg/day p.o. b.Simvastatin \=20mg/day p.o. c.Pitavastatin\=2mg/day p.o. d.Rosuvastatin \=40mg/day p.o. e.Pravastatin \=40mg/day p.o. f.Lovastatin \=40mg/day p.o. g.Fluvastatin \=80 mg/day p.o., Subjects must be naïve to any genotyping test of the following genes: SCLO1B1, ABCG2, CYP2C9, CYP3A4, CYP3A5 and HMGCR., Subjects must be willing to comply and adhere to any treatment plan modifications established and to the procedures specified in this protocol., Women of childbearing potential must commit not to become pregnant. Subjects must be willing to use highly effective contraceptive methods or have practiced sexual abstinence during the study.

•Subject is currently taking ubiquinone (Q10\) supplements., Known personal or family history of statin\-associated autoimmune myopathy or HMG\-CoA reductase disorder., Pregnant or breastfeeding women, Subject has a personal history or analytical evidence of one of the following disorders: a.Any contraindications to statin administration as revealed in the summary of product characteristics (SmPCs) for statins. b.Prior SAMS if subject is not statin\-naïve., Any condition or situation deemed by the investigator precluding or interfering with the present study.