Ignite Creation Date:
2024-05-05 @ 10:33 PM
Last Modification Date:
2024-10-26 @ 10:20 AM
Study NCT ID:
NCT01130246
Status:
TERMINATED
Last Update Posted:
2012-10-31
First Post:
2010-04-19
Brief Title:
VISTA-16 Trial Evaluation of Safety and Efficacy of Short-term A-002 Treatment in Subjects With Acute Coronary Syndrome
Sponsor:
Anthera Pharmaceuticals
Organization:
Anthera Pharmaceuticals
Study Overview
Official Title:
VISTA-16 Trial Evaluation of the Safety and Efficacy of Short-Term A-002 Treatment in Subjects With Acute Coronary Syndromes
Status:
TERMINATED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of efficacy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VISTA-16
Brief 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 subjects LDL-C is 100 mgdL 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None