VISTA-16 Trial: Evaluation of the Safety and Efficacy of Short-Term A-002 Treatment in Subjects With Acute Coronary Syndromes
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 on Weeks 1, 2, 4, 8, and 16. A 6 month follow-up visit will also occur.
Inclusion Criteria:
Men and women ≥40 years of age
Written informed consent from the subject
A diagnosis of unstable angina, non-ST-segment elevation myocardial infarction (NSTEMI), or ST-segment elevation myocardial infarction (STEMI)
Unstable angina is defined as:
NSTEMI is defined as:
STEMI is defined as:
All subjects must have the presence of at least one of the following risk factors:
Diabetes Mellitus or
Presence of any 3 of the following characteristics of metabolic syndrome
history of cerebrovascular disease (stroke or TIA) or
history of peripheral vascular disease or
previous CABG or
previous documented myocardial infarction or
previous coronary revascularization
Subjects must be randomized within ≤96 hours of hospital admission for the index event, or if already hospitalized, within ≤96 hours of index event diagnosis
Revascularization, if required or planned, must occur prior to randomization
Exclusion Criteria:
So Australia, Australia
Jihlavska, Brno 62500, Czechia
Bad Friedrichshall, 74177, Germany
Semmelweis, Kistarcsa 2143, Hungary
Budapest, Pest County 1076, Hungary
Budapest, Pest County 1097, Hungary
Hyderabad, Andhra Pradesh 500082, India
Secunderabad, Andhra Pradesh 500003, India
Secunderabad, Andhra Pradesh 500003, India
Wroc³aw, Lower Silesian Voivodeship 53-114, Poland
Barnaui, 656099, Russia
Kangwon-do, 220-701, South Korea