Atorvastatin Pre-Treatment Study In Asian Patients With Acute Coronary Syndrome

Phase 4 Completed 499 enrolled Viatris Inc.

RandomizedParallel-groupOpen-labelPrevention

Summary

This present study is specifically designed to examine the efficacy and safety of a high pre-treatment dose of atorvastatin in Asian patients with NSTE-ACS in China and the Republic of Korea, by using a treatment paradigm similar to that employed in the ARMYDA-ACS study.

Timeline

Start: 2008-09
Primary completion: 2010-04
Completion: 2010-04

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

registry analysis (unspecified test); Atorvastatin vs Usual Care; p = 0.80; Odds Ratio (OR) 0.93 (95% CI 0.5104 to 1.6846); Regression, Logistic NCT00728988 ↗

paper did not find a beneficial effect compared with usual post-PCI atorvastatin 40 mg/day treatment. PMID 24216317 ↗

Publications

Jang Y, Zhu J, Ge J, Kim YJ, Ji C, Lam W. Preloading with atorvastatin before percutaneous coronary intervention in statin-naive Asian patients with non-ST elevation acute coronary syndromes: A randomized study. J Cardiol. 2014 May;63(5):335-43. doi: 10.1016/j.jjcc.2013.09.012. Epub 2013 Nov 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Atorvastatin	Small molecule	40 mg	—