NCT01130246

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

VISTA-16 Trial: Evaluation of the Safety and Efficacy of Short-Term A-002 Treatment in Subjects With Acute Coronary Syndromes

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5,189 (actual)
• Sponsor: Anthera Pharmaceuticals · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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).

Detailed description

A double-blind randomized parallel group placebo controlled study in subjects presenting with an ACS. Up to 6500 subjects will be randomized to receive either A-002 500 mg once daily (QD) or placebo tablets in addition to atorvastatin QD and standard of care. Treatment will be 16 weeks in duration. The dose of atorvastatin shall be adjusted after 8 weeks if subject's LDL-C is ≥100 mg/dL, but otherwise must remain stable throughout the16-week duration of study. The survival status for all enrolled subjects will be ascertained 6 months after they complete the study. Randomization must occur within ≤96 hours of hospitalization for the index ACS event, or if already hospitalized, within ≤96 hours of index event diagnosis. Follow-up visits will occur on Weeks 1, 2, 4, 8, and 16. A 6 month follow-up visit will also occur.

Conditions

• Acute Coronary Syndrome

Interventions

Type	Name	Description
DRUG	A-002, varespladib methyl	A-002 administered once daily in addition to atorvastatin and standard of care
DRUG	Placebo	Placebo administered once daily in addition to atorvastatin and standard of care

Timeline

• Start date: 2010-05-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2010-05-25
• Last updated: 2012-10-31

Locations

362 sites across 17 countries: United States, Australia, Canada, Czechia, Georgia, Germany, Hungary, India, Italy, Lebanon, Netherlands, New Zealand, Poland, Russia, South Korea, Spain, Ukraine