Trial DesignsEffect of rosuvastatin 20 mg versus rosuvastatin 5 mg plus ezetimibe on statin side-effects in elderly patients with atherosclerotic cardiovascular disease: Rationale and design of a randomized, controlled SaveSAMS trial
Section snippets
Study overview and objectives
The SaveSAMS trial (the effects of high-dose statin versus low-dose statin plus ezetimibe on SAMS and on reaching target LDL-cholesterol levels among older patients with ASCVD) is a prospective, multicenter, open-labeled, randomized comparison trial. This trial was initiated with grant support from Yuhan (Seoul, Korea). Other than the funding, the company will not be involved in any aspect of the study process, including protocol development, site selection, data collection, or data analysis.
Discussion
The 2019 ESC and European Atherosclerosis Society (EAS) guidelines on the management of dyslipidemia recommend high-intensity statins or maximally tolerated statin therapy for patients at very high risk for ASCVD, irrespective of primary (Class IA) and secondary prevention (Class IC).5 Moreover, based on the evidence demonstrating further reductions in the risk of ASCVD events by adding nonstatin lipid-lowering therapy to a maximally tolerated dose of statin, the 2018 AHA/ACC and 2019 ESC/EAS
Conflict of interests
None reported.
Acknowledgments
None.
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