Vorapaxar as an Add-On Antiplatelet Therapy in Patients With and Without Diabetes Mellitus
Status:
Completed
Trial end date:
2019-02-14
Target enrollment:
Participant gender:
Summary
Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 receptor inhibitor, more frequently
clopidogrel, represents the standard of care for the long-term secondary prevention of
atherothrombotic events in patients with myocardial infarction (MI) or peripheral arterial
disease (PAD). However, rates of ischemic recurrences remain high. Vorapaxar is a
protease-activated receptor (PAR)-1 inhibitor, which exerts potent inhibition of
thrombin-mediated platelet aggregation. Patients with diabetes mellitus (DM) are known to be
at increased risk of recurrent atherothrombotic events, which translates into worse outcomes,
despite the use of standard of care therapy. This is in part due to the hyperreactive
platelet phenotype, which characterizes DM patients, and to inadequate response to oral
antiplatelet agents, including clopidogrel. Therefore, vorapaxar is an attractive treatment
option for DM patients with a prior MI. The pharmacodynamic (PD) effects of vorapaxar in DM
patients and how these may differentiate from non-DM patients has not been explored. Further,
the role of vorapaxar as part of a dual antithrombotic treatment regimen combined with
clopidogrel (and stopping aspirin) represents another important area of clinical interest.
The proposed prospective, parallel-design study conducted in patients post-MI or with PAD
with and without DM will aim the assess the pharmacodynamic effects of vorapaxar in addition
to standard DAPT with aspirin and clopidogrel as well as in combination with clopidogrel only
following aspirin withdrawal.