Fluvastatin in the Therapy of Acute Coronary Syndrome

Phase 4 Completed 1000 enrolled Novartis Ministry of Health, Czech Republic · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

This study is to evaluate the safety and efficacy of fluvastatin versus placebo, dosed shortly after or immediately when the coronary event occurs.

Timeline

Start: 2003-11
Primary completion: 2007-02
Completion: —

Outcome

Missed primary endpoint

paper This study failed to prove the effect of fluvastatin given as first-line therapy of ACS on serum markers of inflammation and plaque instability. PMID 20500832 ↗

Publications

Ostadal P, Alan D, Vejvoda J, Kukacka J, Macek M, Hajek P, Mates M, Kvapil M, Kettner J, Wiendl M, Aschermann O, Slaby J, Holm F, Telekes P, Horak D, Blasko P, Zemanek D, Veselka J, Cepova J. Fluvastatin in the first-line therapy of acute coronary syndrome: results of the multicenter, randomized, double-blind, placebo-controlled trial (the FACS-trial). Trials. 2010 May 25;11:61. doi: 10.1186/1745-6215-11-61.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fluvastatin	Other / unclassified	80 mg	—