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



Status:Archived
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:November 2009
End Date:September 2011

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The ASPECT Trial: A Phase III, Randomized, Double-Blind Crossover Trial of Apadenoson for the Detection of Myocardial Perfusion Defects Using Single-Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI)


The purpose of this study is to see whether apadenoson is as effective as adenosine when
used as a pharmacological stress agent in myocardial SPECT-Imaging to detect defects in the
supply of blood to the heart muscle (myocardial perfusion defects). The study will also
look at whether apadenoson is better tolerated than adenosine when used in 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.


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Wichita, Kansas 67206
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1720 2nd Ave S
Birmingham, Alabama 35233
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1 Brookings Drive
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 (314) 935-5000
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1120 15th Street
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171 Ashley Avenue
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281 W. Lane Ave
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2900 W Queen Ln
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