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Study of the Safety and Efficacy of Apadenoson for Detection of Myocardial Perfusion Defects Using SPECT MPI (ASPECT2)

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ClinicalTrials.gov Identifier: NCT01313572
Recruitment Status : Terminated
First Posted : March 11, 2011
Last Update Posted : May 1, 2012
Sponsor:
Collaborator:
PPD
Information provided by (Responsible Party):
Forest Laboratories

Tracking Information
First Submitted Date  ICMJE March 4, 2011
First Posted Date  ICMJE March 11, 2011
Last Update Posted Date May 1, 2012
Study Start Date  ICMJE August 2011
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2011)
Presence of myocardial perfusion defect based on SPECT-MPI [ Time Frame: Up to 2 hours after study drug administration in Period 1 and Period 2 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01313572 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2011)
Incidence and subject rated intensity of most commonly reported side effects associated with use of adenosine compared to apadenoson in SPECT-MPI [ Time Frame: Up to 2 hours after administration of study drug in Period 2 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Safety and Efficacy of Apadenoson for Detection of Myocardial Perfusion Defects Using SPECT MPI
Official Title  ICMJE The ASPECT2 Trial: A Phase 3, Randomized, Double-Blind Trial of Apadenoson for the Detection of Myocardial Perfusion Defects Using Single-Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI)
Brief 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 (SPECT-MPI)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.
Detailed 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. This is a multi-center, randomized double-blind study to compare the tolerability 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 1250 subjects. Eligible subjects will then be randomized in a 1:1 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 670 subjects who complete both studies. The agreement of the results from the two adenosine:adenosine stress tests will be compared to that from the adenosine:apadenoson tests to assess efficacy. The incidence and intensity of commonly reported side effects will be compared to evaluate improved tolerability.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • Drug: Apadenoson SPECT-MPI
    Apadenoson single bolus IV injection 100 or 150 ug
    Other Names:
    • BMS068645
    • 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
Study Arms  ICMJE
  • 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
    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 the active comparator: adenosine.
    Interventions:
    • Drug: Apadenoson SPECT-MPI
    • Drug: Adenosine SPECT-MPI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 27, 2012)
197
Original Estimated Enrollment  ICMJE
 (submitted: March 10, 2011)
670
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Referred for a clinically indicated rest/pharmacologic stress SPECT-MPI test
  • High pretest probability (90% or greater) of CAD based on the ACC/AHA guidelines for relative risk, or past medical h/o CAD

Exclusion Criteria:

  • 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
  • Known history of cerebral vascular accident or suspected transient ischemic attack within 30 days prior to signed informed consent
  • Current significant medical, surgical, psychiatric, or other illness or pathology that could potentiate any adverse pharmacological event associated with an investigational drug
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Belgium,   Brazil,   Netherlands,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01313572
Other Study ID Numbers  ICMJE PGX-III-AP-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Forest Laboratories
Study Sponsor  ICMJE Forest Laboratories
Collaborators  ICMJE PPD
Investigators  ICMJE
Study Director: David B Bharucha, MD, PhD, FACC Forest Laboratories
PRS Account Forest Laboratories
Verification Date April 2012

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