Vorapaxar in Patients With Prior Myocardial Infarction Treated With Prasugrel and Ticagrelor
Status:
Completed
Trial end date:
2020-01-01
Target enrollment:
Participant gender:
Summary
Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 receptor inhibitor represents the
standard of care for the long-term secondary prevention of atherothrombotic events in
patients with myocardial infarction (MI). However, rates of ischemic recurrences remain high,
which may be in part due to the fact that other platelet signaling pathways, such as
thrombin-induced platelet aggregation, continue to be activated. Vorapaxar is a
protease-activated receptor (PAR)-1 inhibitor, which exerts potent inhibition of
thrombin-mediated platelet aggregation. It is approved for clinical use by the Food and Drug
Administration for the reduction of thrombotic cardiovascular events in patients with a
history of MI or with peripheral arterial disease. However, to date clinical trial experience
with vorapaxar has been almost exclusively with the P2Y12 receptor inhibitor clopidogrel and
the effects of vorapaxar in combination with antiplatelet therapy including prasugrel or
ticagrelor, is largely unexplored. Further, the role of vorapaxar as part of a dual
antithrombotic treatment regimen, in addition to a novel P2Y12 receptor inhibitor, with
withdrawal of aspirin, represents another important area of clinical interest as it has the
potential to maximize ischemic protection while reducing the risk of bleeding. The proposed
prospective, randomized, parallel-design, open label, study conducted in a real world
clinical setting of post-MI patients will aim to assess the pharmacodynamic effects of
vorapaxar in addition to antiplatelet therapy with a novel P2Y12 receptor inhibitor
(prasugrel or ticagrelor) with and without aspirin.