Evaluating the efficacy and adherence of administration of a PCSK9 inhibitor Alirocumab in Aboriginal participants with hypercholesterolaemia
South Australian Health and Medical Research Institute
200 participants
Dec 20, 2017
Interventional
Conditions
Summary
Studies have shown that abnormal amounts of fat (lipids) in the blood are an important cause of heart disease and stroke. Some treatments that lower blood fat level reduce the risk of heart attacks or other cardiovascular events. One type of cholesterol, low density lipoprotein cholesterol (LDL-c), has been found to be a bad type of cholesterol. The purpose of this study is to see if we can significantly reduce blood levels of LDL-cholesterol when the medication Alirocumab (study treatment) is injected under the skin once per month. Participation in this study will last for 24 weeks in total. Once commenced in the study, participants will receive an inactive dose (placebo) for 4 weeks to make sure they don’t have any troubles with the ‘small’ injections. They will then be randomly (like the toss of a coin) assigned to receive active treatment, or continue on the inactive (placebo) therapy. This is important to make sure we can tell how well the study treatment does its job.
Eligibility
Inclusion Criteria10
- Aboriginal adults able to give informed, written consent
- 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%
- 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
Exclusion Criteria12
- Prior use of PCSK9 inhibition treatment
- Type 1 diabetes or poorly controlled type 2 diabetes (HbA1c >10%) at screening
- Estimated glomerular filtration rate (eGFR) <30ml/min/1.73m2
- Thyroid stimulating hormone (TSH) < lower limit of normal (LLN) or 1.5x upper limit of normal (ULN)
- Creatine kinase (CK) >5x ULN
- 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.
- Known major active infection, or major haematology, renal, metabolic, gastrointestinal or endocrine dysfunction
- 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)
- 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
- Unable to give informed consent
- Not willing or able to attend monthly follow ups
- Any other information that the investigator considers will limit the ability of the participant to complete all study associated procedures
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Interventions
Administration of a PCSK9 inhibitor Alirocumab 300mg subcutaneously every 4 weeks for 20 weeks. Participants who met all eligibility criteria will enter a run-in period from Day 1 to Week 4. All participants will receive placebo 300mg SC on Day 1 to confirm tolerance of SC administration prior to randomisation at Week 4. Two sub-cutaneous injections of 150mg Alirocumab or placebo (1mL each) will be administered by the study nurse at each 4 weekly visit. The Investigator/designee must maintain accurate and adequate records of dates and amounts administered of the investigational product.
Locations(3)
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ACTRN12616000871448