VISTA-16 Trial: Evaluation of Safety and Efficacy of Short-term A-002 Treatment in Subjects With Acute Coronary Syndrome (VISTA-16)
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|ClinicalTrials.gov Identifier: NCT01130246|
Recruitment Status : Terminated (Lack of efficacy)
First Posted : May 25, 2010
Last Update Posted : October 31, 2012
|Condition or disease||Intervention/treatment||Phase|
|Acute Coronary Syndrome||Drug: A-002, varespladib methyl Drug: Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5189 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||VISTA-16 Trial: Evaluation of the Safety and Efficacy of Short-Term A-002 Treatment in Subjects With Acute Coronary Syndromes|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||March 2012|
Experimental: A-002 500 mg
Once daily oral administration
Drug: A-002, varespladib methyl
A-002 administered once daily in addition to atorvastatin and standard of care
Placebo Comparator: Matched Placebo
Once daily oral administration
Placebo administered once daily in addition to atorvastatin and standard of care
- Primary Objective of the Study [ Time Frame: 16 weeks ]To determine whether 16 weeks of treatment with A-002 plus atorvastatin and standard of care is superior to placebo plus atorvastatin and standard of care for reducing the hazard of the first occurrence of the combined endpoint of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or documented unstable angina with objective evidence of ischemia requiring hospitalization.
- Secondary Objective of the Study [ Time Frame: 2, 4, 8, 16 weeks and 6 months ]To determine whether A-002 plus atorvastatin and standard of care is superior to placebo plus atorvastatin and standard of care for reducing the occurrence of the hazard of the combined endpoint of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke or documented unstable angina with objective evidence of ischemia requiring hospitalization or multiple occurrences of the non-fatal components of the composite primary endpoint.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01130246