2023-509418-12-00招募中4 期
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
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz11 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2024年5月21日最近更新:
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 216
- 试验地点
- 11
- 主要终点
- A composite variable that includes the incidence of patients with a clinically relevant statin-associated musculoskeletal symptom (defined as a combination of a SAMS-CI score ≥7 and a NPRS score ≥3) in the 9-month follow-up period or a serum CPK greater than three times the upper limit of normality prespecified by each centre’s laboratory, related to the statin.
研究概览
简要总结
To assess the efficacy of a statin preemptive genotyping strategy in reducing statin associated musculoskeletal adverse events.
研究设计
- 分配方式
- Randomized
- 主要目的
- Phase IV, multicentre, controlled, randomized, parallel and single-blind adaptive clinical trial.
- 盲法
- Single (Subject)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
A composite variable that includes the incidence of patients with a clinically relevant statin-associated musculoskeletal symptom (defined as a combination of a SAMS-CI score ≥7 and a NPRS score ≥3) in the 9-month follow-up period or a serum CPK greater than three times the upper limit of normality prespecified by each centre’s laboratory, related to the statin.
A composite variable that includes the incidence of patients with a clinically relevant statin-associated musculoskeletal symptom (defined as a combination of a SAMS-CI score ≥7 and a NPRS score ≥3) in the 9-month follow-up period or a serum CPK greater than three times the upper limit of normality prespecified by each centre’s laboratory, related to the statin.
次要结局
- 9-month change in percentual LDLc defined as the percentage difference between LDLc values at 9 months minus baseline LDLc.
- Percentage of patients that require either a statin dose modification/withdrawal or additional lipid-lowering therapy after 9 months in order to meet LDLc goals.
- The difference between the costs of the intervention and all its surrounding procedures combined with the costs derived from the events in the intervention arm when compared to the costs derived from the events in the control arm alone over the 9-month follow-up period. Additionally, the ratio between cost differences and efficacy differences between both arms may be calculated.
- Novel prognostic and predictive genetic biomarkers of statin-related adverse events and efficacy will be assessed in outlier subject’s/or any given subject for quality control reasons trough techniques not readily available at all centres, and only available at CNIO as well as genome-wide association studies when applicable. Aforementioned techniques may vary at CNIOs criteria and may include (but are not limited to) assays and/or next generation sequencing techniques.
- Percentage of participants who experience a 4-component exploratory endpoint consisting of cardiovascular death, nonfatal myocardial infarction (MI), resuscitated cardiac arrest, or hospitalization for unstable angina
- Difference in Morisky-Green (MMAS-8) questionnaire adherence levels/score between both study arms.
- Difference in Numeric Pain Rating Scale (NPRS) score between both study arms. Categories will be as follow: 0-3 no pain; 3-5 moderate pain; 5-7 intense pain; 7-9 very intense pain; 9-10 extreme pain.
研究者
Alberto M. Borobia
Scientific
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
研究点 (11)
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