Acute Coronary Syndrome
Conditions
Keywords
Unstable Angina, STEMI, NSTEMI, ACS, Acute Coronary Syndrome, C14.280.647.124, C14.280.647.500
Brief summary
The objective of this study is to evaluate the safety and efficacy of A 002 when added to high dose atorvastatin in subjects with an acute coronary syndrome (ACS)
Detailed description
This is a double-blind randomized parallel group placebo controlled study in subjects presenting with an ACS. Subjects will be randomized to receive either A 002 500 mg once daily (QD) or placebo tablets in addition to 80 mg atorvastatin QD. Randomization must occur within ≤96 hours of hospital admission for the index ACS event, or, if already hospitalized, within ≤96 hours of index event diagnosis. Follow-up visits will occur at Weeks 2, 4, 8, 12, 16, 20, and 24 post-randomization; and monthly thereafter until study completion. All enrolled subjects will remain on treatment until all subjects have been treated for a minimum of 24 weeks or until the occurrence of a Major Adverse Cardiac Event (MACE). At that point, all active subjects (those who have not early withdrawn or those that have not already had a MACE) will be brought in for a Final Study Visit. Subjects who complete the Final Study Visit may be eligible to enroll in an open-label extension study for up to 2 years total study drug exposure.
Interventions
DRUGVarespladib Methyl (A-002)
2 Tablets (250 mg each) once daily for at least 24 weeks in combination with Atorvastatin (80 mg tablet once a day).
Sponsors
Anthera Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women ≥18 years of age * A diagnosis of unstable angina, NSTEMI, or STEMI * Any one of the following criteria: Diabetes, CRP ≥2 mg/L, or metabolic syndrome * Subjects must be randomized within 96 hours of the index event * Percutaneous revascularization, if required or planned, must occur prior to randomization
Exclusion criteria
\- Subjects must NOT meet any of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean percent changes in LDL hs-CRP, sPLA2 and other biomarkers will be compared between the 2 treatment groups. | 8 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| The occurrence of MACEs will be examined for any treatment-related trends at study completion. | End of Study |
Countries
Georgia, Russia, Ukraine
Outcome results
None listed