Phase 2 Study in Vascular Inflammation on Patients After an Acute Coronary Syndrome Event
- Registration Number
- NCT00552188
- Lead Sponsor
- Tallikut Pharmaceuticals, Inc.
- Brief Summary
The purpose of this study is to determine the effect of VIA-2291 as compared to placebo on vascular inflammation following 24 weeks of dosing.
- Detailed Description
The effect of VIA-2291 on vascular inflammation will be assessed through 18FDG PET vascular imaging measurements and various biomarkers after 24 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VIA-2291 VIA-2291 VIA-2291 100mg Placebo Placebo Matching placebo
- Primary Outcome Measures
Name Time Method Change From Baseline in Plaque Imaging After 24 Weeks Baseline and 24 Weeks To evaluate the effect of VIA-2291 100 mg relative to placebo on the change from baseline in the target (plaque) to background (blood) ratio (TBR) from an index vessel (either right carotid, left carotid or ascending aorta) based on the standardized 18fluorodeoxy glucose (FDG) uptake measured with PET in patients with acute coronary syndrome and vascular inflammation after 24 weeks of daily dosing.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Plaque Imaging After 6 Weeks Baseline and 6 Weeks To evaluate the effect of VIA-2291 100 mg relative to placebo on the change from baseline in the TBR from an index vessel (either right carotid, left carotid or ascending aorta) based on the standardized 18FDG uptake measured with PET in patients after 6 weeks of daily dosing.
Trial Locations
- Locations (1)
VIA Pharmaceuticals
🇺🇸Princeton, New Jersey, United States