ACTRN12616000871448终止3 期
Evaluating the efficacy and adherence of administration of a PCSK9 inhibitor Alirocumab in Aboriginal participants with hypercholesterolaemia
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Aboriginal adults able to give informed, written consent
- •2. Individuals deemed to be at high cardiovascular risk of cardiovascular event on the basis of either:
- •(a) An established history of atherosclerotic cardiovascular disease
- •(b) Type 2 diabetes mellitus and one of the following risk factions
- •(i) microalbuminuria or macroalbuminuria with estimated glomerular filtration rate (eGFR) >30ml/min/1.73m2
- •(ii) hypertension (BP >140/90)
- •(iii) age >50 years
- •(iv) current smoker
- •(c) Framingham risk score >15%
- •3. LDL-C >1.8mmol/L on stable doe (no change in last 4 weeks) of statin therapy and anticipated to remain on stable dose over the course of the study
排除标准
- •1. Prior use of PCSK9 inhibition treatment
- •2. Type 1 diabetes or poorly controlled type 2 diabetes (HbA1c >10%) at screening
- •3. Estimated glomerular filtration rate (eGFR) <30ml/min/1.73m2
- •4. Thyroid stimulating hormone (TSH) < lower limit of normal (LLN) or 1.5x upper limit of normal (ULN)
- •5. Creatine kinase (CK) >5x ULN
- •6. Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 times the ULN as determined by analysis at screening.
- •7. Known major active infection, or major haematology, renal, metabolic, gastrointestinal or endocrine dysfunction
- •8. History of malignancy within the last 5 years (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in-situ, or stage 1 prostate cancer)
- •9. Female participants cannot be pregnant or breast feeding and premenopausal participants must be willing to use at least 1 highly effective method of birth control during treatment and for an additional 12 weeks after the end of treatment
- •10. Unable to give informed consent
- •11. Not willing or able to attend monthly follow ups
- •12. Any other information that the investigator considers will limit the ability of the participant to complete all study associated procedures
研究者
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