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

Last updated: April 27, 2012
Sponsor: Forest Laboratories
Overall Status: Terminated

Phase

3

Condition

Myocardial Ischemia

Thrombosis

Cardiac Disease

Treatment

N/A

Clinical Study ID

NCT00990327
PGX-III-AP-001
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • High pretest probability of CAD based on the ACC/AHA guidelines for relative risk, orpast medical h/o CAD

Exclusion

Exclusion Criteria:

  • Ingestion of a caffeinated or methylxanthine food substance (e.g. chocolate, cocoa)within 24 hours before receiving apadenoson or adenosine

  • Treatment with dipyridamole within 24 hours, or theophylline, aminophylline, orpentoxifylline within 72 hours (or 4 half-lives, whichever is longer) prior toreceiving apadenoson or adenosine

  • Acute MI, new onset of ischemia or PCI within 30 days prior to SPECT-MPI at eitherPeriod 1 or Period 2; or CABG within 90 days prior to SPECT-MPI at either Period 1 orPeriod 2

  • Active severe asthma or severe chronic obstructive pulmonary disease (COPD) which, inthe Investigator's opinion, places the subject at risk for severe bronchoconstriction

  • History or evidence of clinically significant cardiac condition and rhythm disorder,in the absence of a functioning permanently implanted pacemaker

  • Hemodynamically significant valvular disease, outflow tract obstruction, oruncontrolled severe hypertension

  • Current significant medical, surgical, psychiatric, or other illness or pathology thatcould potentiate any adverse pharmacological event associated with an investigationaldrug

  • Subject with past medical history of hepatitis B or C, or recent hepatitis A

  • Pretreatment hypotension (systolic BP < 90 mm Hg) or tachycardia (HR > 100 bpm)

  • Known history of cerebral vascular accident or suspected transient ischemic attackwithin 30 days prior to signed informed consent

Study Design

Total Participants: 863
Study Start date:
November 01, 2009
Estimated Completion Date:
April 30, 2012

Study Description

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:apadenoson tests to assess efficacy. The incidence and intensity of commonly reported side effects will be compared to evaluate improved tolerability.

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