Pragmatic clinical trial to assess the utility of SLCO1B1, ABCG2, and CYP2C9 preepmtive genotyping and pharmacogenetics training on the incidence of musculoskeletal adverse reactions in patients treated with statins in primary and specialized care.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- The incidence of musculoskeletal adverse reactions induced during the first 6 months of treatment (measurement at 6 months).
研究概览
简要总结
The main objective is to evaluate the differences in the outcomes of musculoskeletal adverse reactions in a group of patients treated with statines according to clinical practice (control group) vs patients with a prescribed statin based on the prosprective genotyping of SLCO1B1, ABCG2 and CYP2C9 (intervention group), in a follow-up period of 6 months in patients treated from primary attention (healthcare centers) and hospitals ( Hospital de La Princesa).
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
- •Adults, with any type of cardiovascular risk (high, moderate or low): a) In which it is indicated statins as a treatment at any dose. b) Pacients who must be outpatients, recruited in a health care centre (primary attention) or in hospitals (primary or secundary prevention). c) Pacients who must have never taken statins or who have started statin treatment less tan 15 days ago, or who had their statin dose increased or changed to a more potent statin due to bad control of LDL levels in the last 15 days. d) Patients who have to give their inform consent form written
排除标准
- •a) Pacients who statins are not prescribed as standard clinical practice. b) Pacients who suffer a malignant or terminal disease whose live expectancy will be less than 6 months. c) Pacients who have statins contraindicated for treatment d) Pregnant or breast-feeding patients.
结局指标
主要结局
The incidence of musculoskeletal adverse reactions induced during the first 6 months of treatment (measurement at 6 months).
The incidence of musculoskeletal adverse reactions induced during the first 6 months of treatment (measurement at 6 months).
次要结局
- The incidence of musculoskeletal adverse reactions at 12 months or longer follow up.
研究者
Francisco Abad Santos
Scientific
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa