Evaluating the efficacy and adherence of administration of a PCSK9 inhibitor Alirocumab in Aboriginal participants with hypercholesterolaemia

South Australian Health and Medical Research Institute0 个研究点目标入组 200 人开始时间: 2016年7月4日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•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

•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

发起方