VISTA-16 Trial: Evaluation of Safety and Efficacy of Short-term A-002 Treatment in Subjects With Acute Coronary Syndrome
Status: | Archived |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | Any |
Updated: | 7/1/2011 |
Start Date: | May 2010 |
End Date: | February 2012 |
VISTA-16 Trial: Evaluation of the Safety and Efficacy of Short-Term A-002 Treatment in Subjects With Acute Coronary Syndromes
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).
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
at Hours 6, 12, 24, 48, 72, 96 and Weeks 1, 2, 4, 8, and 16.
We found this trial at
12
sites
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