Abstract
Background: CSL112, a novel formulation of apoA-I purified from human plasma and reconstituted to form HDL particles, is in development for the treatment of patients with coronary artery disease. Prior data with a similar compound (CSL111) indicated a potential short-term platelet inhibitory effect. We assessed the potential antiplatelet effects of CSL112 in a phase 2a multicenter, randomized, ascending dose study in subjects with stable atherosclerotic disease. Methods: Subjects (n=44) on aspirin (75-325 mg/day) and clopidogrel (75 mg/day, n=37) or prasugrel (10 mg/day, n=7) for >30 days in addition to standard of care therapy were randomized to a single dose of placebo or CSL112: 1.7, 3.4, and 6.8g. Conventional platelet aggregation in response to 2 mM arachidonic acid (AA), 5 and 10 μM adenosine diphosphate (ADP), and 4μg/mL collagen were performed at baseline and 8, 12, 24 and 48 h post-dosing. The change from baseline in maximal aggregation was determined and compared by ANOVA analysis among the treatments at any time point. Results: Baseline characteristics were well balanced across treatment groups. Compared to placebo, CSL112 did not show any time or dose dependent effects on maximum platelet aggregation in response to any agonist (p>0.05 for all tests) [Table]. Conclusion: CSL112, when co-administered with dual antiplatelet therapy, does not significantly influence platelet aggregation in response to AA, ADP and collagen. Based on these data, it is anticipated that CSL112 will not affect hemostasis when administered with concomitant antiplatelet therapies.
Published Version
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