Phase 2 Study in Vascular Inflammation on Patients After an Acute Coronary Syndrome Event
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Effect of VIA-2291, a 5-Lipoxygenase Inhibitor, on Vascular Inflammation in Patients After an Acute Coronary Syndrome Event|
- Change From Baseline in Plaque Imaging After 24 Weeks [ Time Frame: Baseline and 24 Weeks ] [ Designated as safety issue: No ]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.
- Change From Baseline in Plaque Imaging After 6 Weeks [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]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.
|Study Start Date:||October 2007|
|Study Completion Date:||November 2009|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
100 mg, oral dosing, 1 time daily for 24 weeks
Placebo Comparator: Placebo
oral dosing, 1 time daily for 24 weeks
The effect of VIA-2291 on vascular inflammation will be assessed through 18FDG PET vascular imaging measurements and various biomarkers after 24 weeks.
|United States, California|
|San Francisco, California, United States, 94111|
|United States, New Jersey|
|Princeton, New Jersey, United States, 08540|
|Study Director:||Rebecca Taub, MD||VIA Pharmaceuticals|