Study of the Safety and Efficacy of Apadenoson for Detection of Myocardial Perfusion Defects Using SPECT MPI

Adenosine is an effective vasodilator used in SPECT-Myocardial Perfusion Imaging
(SPECT-MPI). However, it produces transient symptoms that are poorly tolerated by most
subjects. PGxHealth has designed a multi-center, randomized crossover, double-blind study to
compare the safety and effectiveness of apadenoson to adenosine (Adenoscan®) in SPECT-MPI.
Subjects who are clinical candidates for SPECT-MPI will be enrolled to undergo two
sequential SPECT-MPI studies. The first study will use adenosine as the stress agent in
approximately 1300 subjects. Eligible subjects will then be randomized in a 1:2 assignment
ratio to receive a second SPECT-MPI using either adenosine or apadenoson as the
pharmacologic stress agent, with the goal of obtaining a total of 753 subjects who complete
both studies. The similarity of the results from the two adenosine:adenosine stress tests
will be compared to those from the adenosine:apadenosine tests to assess efficacy. The
incidence and intensity of commonly reported side effects will be compared to evaluate
improved tolerability.