Efficacy, Safety and Cost-effectiveness of 40 mg versus 80 mg Atorvastatin in a Cohort of South Asian Patients with Acute Coronary Syndrome: A Protocol for a Randomised Controlled Clinical Trial

Background Most guidelines recommend high-intensity statins for the secondary prevention of acute coronary syndrome(ACS). However, South Asians show more enhanced sensitivity to statin therapy, characterized by greater reduction in low-density lipoprotein cholesterol (LDL-c) levels and higher incidence of adverse effects at higher statin doses. However, there is no reported data on this observation. Therefore, we aimedto compare the efficacy, safety and cost effectiveness of atorvastatin at doses of 40 mg and 80 mg in a cohort of South Asian individuals presenting with ACS. Methods This single-centre, prospective, randomized, controlled, open-labelclinical trial is being conducted among patients naïve for statins admitted with incident ACS to the Colombo North Teaching Hospital, Ragama, Sri Lanka. All patients will have LDL-c measured at baseline and are randomized to receive atorvastatin 40 mg or 80 mg in addition to standard of care. Data are collected using an interviewer administered proforma. Patients are evaluated at6, 12 and 24 weeks for adverse drug reactions and LDL-C level. The primary endpoint is the percentage of patients achieving LDL-C ≤ 70 mg/dL at 12 weeks. This outcomewill be analysed by the intention-to-treat analysis. The safety profile and cost-effectiveness evaluation will be done by applying non-parametric statistics. Discussion This will be the first head-to-head comparison of atorvastatin 40mg and 80mg in a South Asian cohort. The findings will provide evidence on efficacy and safety of prescribing atorvastatin 40 mg dose in South Asians with ACS. Trial Registration - Sri Lanka Clinical Trial Registry, SLCTR/2023/003. Registered 03 March 2023, https://slctr.lk/trials/slctr-2023-003