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

This study has been terminated.
Sponsor:
Collaborator:
PPD
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00990327
First received: October 2, 2009
Last updated: April 27, 2012
Last verified: April 2012

October 2, 2009
April 27, 2012
November 2009
April 2012   (final data collection date for primary outcome measure)
Presence of myocardial perfusion defect as based on SPECT-MPI [ Time Frame: Up to 2 hours after study drug administration in Period 1 and 2 ] [ Designated as safety issue: Yes ]
Presence of myocardial perfusion defect as based on SPECT-MPI [ Time Frame: 1-2 hours after study drug administration in Period 1 and 2 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00990327 on ClinicalTrials.gov Archive Site
Incidence and patient rated intensity of most commonly reported side effects (e.g. dyspnea, flushing, chest pain, headache) associated with use of adenosine compared to apadenoson in SPECT-MPI [ Time Frame: 1 hour after Period 2 study drug administration ] [ Designated as safety issue: No ]
Incidence and patient rated intensity of most commonly reported side effects (e.g. dyspnea, flushing, chest pain, headache) associated with use of adenosine in SPECT-MPI [ Time Frame: 1 hour after Period 2 study drug administration ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of the Safety and Efficacy of Apadenoson for Detection of Myocardial Perfusion Defects Using SPECT MPI
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:apadenoson tests to assess efficacy. The incidence and intensity of commonly reported side effects will be compared to evaluate improved tolerability.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Coronary Artery Disease
  • Drug: Apadenoson SPECT-MPI
    Apadenoson single bolus IV injection 100 or 150 ug
    Other Name: DPC-A78445-00, DPH-068645-01, ATL146e, DWH 146e
  • Drug: Adenosine SPECT-MPI
    Single IV infusion for 6 minutes at a rate of 140 µg/kg body weight per minute.
    Other Name: Adenoscan
  • Experimental: Apadenoson
    In period 1, subjects will receive a clinically-indicated rest/stress gated SPECT-MPI with adenosine. In period 2, subjects will receive a rest/stress gated SPECT-MPI with apadenoson or the active comparator: adenosine.
    Interventions:
    • Drug: Apadenoson SPECT-MPI
    • Drug: Adenosine SPECT-MPI
  • Active Comparator: Adenosine
    In period 1, subjects will receive a clinically-indicated rest/stress gated SPECT-MPI with adenosine. In period 2, subjects will receive a rest/stress gated SPECT-MPI with apadenoson or the active comparator: adenosine.
    Interventions:
    • Drug: Apadenoson SPECT-MPI
    • Drug: Adenosine SPECT-MPI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
863
April 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

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, or pentoxifylline within 72 hours (or 4 half-lives, whichever is longer) prior to receiving apadenoson or adenosine
  • Acute MI, new onset of ischemia or PCI within 30 days prior to SPECT-MPI at either Period 1 or Period 2; or CABG within 90 days prior to SPECT-MPI at either Period 1 or Period 2
  • Active severe asthma or severe chronic obstructive pulmonary disease (COPD) which, in the 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, or uncontrolled severe hypertension
  • Current significant medical, surgical, psychiatric, or other illness or pathology that could potentiate any adverse pharmacological event associated with an investigational drug
  • 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 attack within 30 days prior to signed informed consent
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Brazil
 
NCT00990327
PGX-III-AP-001
No
Forest Laboratories
Forest Laboratories
PPD
Study Director: David B Bharucha, MD, PhD, FACC Forest Laboratories
Forest Laboratories
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP