Why the study?
Does atopaxar improve outcomes and maintain safety in patients with acute coronary syndromes or stable coronary artery disease on top of standard antiplatelet therapy?
Does atopaxar improve outcomes and maintain safety in patients with acute coronary syndromes or stable coronary artery disease on top of standard antiplatelet therapy?
Phase II data suggest atopaxar is generally tolerated but requires phase III trials to definitively assess its efficacy for ischemic events and safety profile regarding liver enzymes and QTcF prolongation.
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Should not yet change practice in ACS or CAD; leaves open efficacy and long-term safety for phase III evaluation.
Atopaxar, also known as E 5555 is a novel reversible protease-activated receptor-1 (PAR-1) thrombin receptor antagonist. To date, Atopaxar has been investigated in phase II trials with focus on safety and tolerability in patients with acute coronary syndromes or stable coronary artery disease on top of standard antiplatelet therapy. Atopaxar was generally well tolerated, however a rise in liver enzymes and prolongation of the QTcF interval were observed. The data suggest, that atopaxar administration may promote some minor bleeding complications, but does not seem to significantly increase the risk of major bleeding. Although not powered for efficacy, the currently available data suggest potential benefits in patients at high risk for recurrent ischemic events on top of standard antiplatelet therapy. In conclusion, more studies (e.g. phase III) are needed to evaluate efficacy and safety of atopaxar.
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Wurster et al. (2012) studied this question.
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