Conditions: Atherosclerosis
Keywords: Coronary artery disease Lipoprotein-associated Phospholipase A2 palpography hs-CRP endothelial function intravascular ultrasound
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 336
Healthy volunteers: no

Brief summary:
IBIS-2 is a study using SB-480848 versus placebo in subjects with angiographically documented coronary heart disease. Endpoints include coronary imaging, endothelial function, biomarkers, safety and tolerability.

Detailed description:
Integrated Biomarker and Imaging Study -2 (IBIS-2): An International, Multicenter, Randomized, Placebo-controlled, Parallel-group, 1 Year Treatment, Integrated Biomarkers and Imaging Study in Subjects with Angiographically Documented Coronary Heart Disease (CHD) to Examine the Effects of the Novel Lipoprotein-associated Phospholipase A2 (Lp-PLA2) inhibitor SB-480848 on Intermediate Cardiovascular Endpoints, Patient Safety and Tolerability.

Arms:
arm 1: Enrolled subjects (subjects with ACS and evidence of myocardial necrosis) will receive 160mg of SB-480848 once daily with food for 52 weeks arm 2: Enrolled subjects (subjects with ACS and evidence of myocardial necrosis) will receive SB-480848 matching placebo once daily with food for 52 weeks arm 3: Enrolled subjects (non-ACS subjects and those ACS subjects without evidence of myocardial necrosis) will receive 160mg of SB-480848 once daily with food for 52 weeks arm 4: Enrolled subjects (non-ACS subjects and those ACS subjects without evidence of myocardial necrosis) will receive SB-480848 matching placebo once daily with food for 52 weeks

Interventions: intervention 1: SB-480848 intervention 2: SB-480848 matching placebo
Intervention descriptions: intervention 1: SB-480848 is available as enteric-coated, free-base micronized tablet intervention 2: Placebo is available as enteric-coated, free-base micronized tablet

Protocol document: