BACKGROUND: Peroxisome proliferator-activated receptors (PPARs) regulate 
transcription of genes involved in glucose uptake, lipid metabolism, and 
inflammation. Aleglitazar is a potent dual PPAR agonist with insulin-sensitizing 
and glucose-lowering actions and favorable effects on lipid profiles and 
biomarkers of cardiovascular risk. The AleCardio trial examines whether the 
addition of aleglitazar to standard medical therapy reduces the risk of 
cardiovascular morbidity and mortality in patients with type 2 diabetes mellitus 
and recent acute coronary syndrome.
STUDY DESIGN: AleCardio is a phase 3, multicenter, randomized, double-blind, 
placebo-controlled trial. A total of 7,228 patients were randomized to 
aleglitazar 150 μg or placebo daily in addition to standard medical therapy. The 
primary efficacy end point is time to the first event of cardiovascular death, 
myocardial infarction, or stroke. Principal safety end points are 
hospitalization due to heart failure and changes in renal function. Treatment 
will continue until 7,000 patients are followed up for at least 2.5 years and 
950 primary end point events are adjudicated.
CONCLUSIONS: AleCardio will establish whether the PPAR-α/γ agonist aleglitazar 
improves cardiovascular outcomes in patients with diabetes and high-risk 
coronary disease.