|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Anthera Pharmaceuticals |
|---|---|
| Information provided by (Responsible Party): | Anthera Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01130246 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Coronary Syndrome |
Drug: A-002, varespladib methyl Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | VISTA-16 Trial: Evaluation of the Safety and Efficacy of Short-Term A-002 Treatment in Subjects With Acute Coronary Syndromes |
| Enrollment: | 5189 |
| Study Start Date: | May 2010 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Drug: Placebo
Placebo administered once daily in addition to atorvastatin and standard of care
|
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.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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:
Presence of any 3 of the following characteristics of metabolic syndrome
Exclusion Criteria:
Contacts and Locations
Show 362 Study Locations
More Information
| Responsible Party: | Anthera Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01130246 History of Changes |
| Other Study ID Numbers: | AN-CVD2233 |
| Study First Received: | April 19, 2010 |
| Last Updated: | March 21, 2012 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada Germany: Federal Institute for Drugs and Medical Devices Italy: Ministry of Health Netherlands: Medicines Evaluation Board (MEB) Poland: Ministry of Health Georgia: Ministry of Health Russia: Pharmacological Committee, Ministry of Health Spain: Spanish Agency of Medicines Ukraine: Ministry of Health Australia: Department of Health and Ageing Therapeutic Goods Administration India: Drugs Controller General of India Czech Republic: Ethics Committee Hungary: Research Ethics Medical Committee |
|
Acute Coronary Syndrome Myocardial Ischemia Heart Diseases Cardiovascular Diseases Angina Pectoris |
Vascular Diseases Chest Pain Pain Signs and Symptoms |