VISTA-16 Trial: Evaluation of Safety and Efficacy of Short-term A-002 Treatment in Subjects With Acute Coronary Syndrome

Phase 3 Terminated 5189 enrolled Anthera Pharmaceuticals

RandomizedParallel-groupDouble-blindTreatment

Summary

The objective of this study is to evaluate the safety and efficacy of short-term A-002 treatment on morbidity and mortality when added to atorvastatin and standard of care in subjects with an acute coronary syndrome (ACS).

Timeline

Start: 2010-05
Primary completion: 2012-03
Completion: 2012-03

Outcome

Missed primary endpoint

Stopped: “Lack of efficacy”

paper The primary end point occurred in 136 patients (6.1%) treated with varespladib compared with 109 patients (5.1%) treated with placebo PMID 24247616 ↗

paper hazard ratio [HR], 1.25; 95% CI, 0.97-1.61; log-rank P = .08 PMID 24247616 ↗

Publications

Nicholls SJ, Kastelein JJ, Schwartz GG, Bash D, Rosenson RS, Cavender MA, Brennan DM, Koenig W, Jukema JW, Nambi V, Wright RS, Menon V, Lincoff AM, Nissen SE; VISTA-16 Investigators. Varespladib and cardiovascular events in patients with an acute coronary syndrome: the VISTA-16 randomized clinical trial. JAMA. 2014 Jan 15;311(3):252-62. doi: 10.1001/jama.2013.282836.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Varespladib	Small molecule	500 mg	Oral