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

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz0 个研究点目标入组 216 人开始时间: 2024年2月22日最近更新: 2024年7月22日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
入组人数: 216

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•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.

发起方