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
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Drug: Apadenoson SPECT-MPI
Drug: Adenosine SPECT-MPI
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 863
Study Start Date: November 2009
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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

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. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00990327

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Locations
United States, Alabama
Forest Investigative Site 152
Birmingham, Alabama, United States, 35294
Forest Investigative Site 250
Mobile, Alabama, United States, 36608
United States, Arizona
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Phoenix, Arizona, United States, 85020
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Phoenix, Arizona, United States, 85006
United States, Arkansas
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Jonesboro, Arkansas, United States, 72401
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Little Rock, Arkansas, United States, 72204
United States, California
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La Mesa, California, United States, 91942
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Mission Viejo, California, United States, 92691
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Murrieta, California, United States, 92562
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Roseville, California, United States, 95661
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Sacramento, California, United States, 95816
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Sacramento, California, United States, 95825
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Santa Rosa, California, United States, 95405
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Walnut Creek, California, United States, 94598
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Hartford, Connecticut, United States, 06102
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Newark, Delaware, United States, 19713
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Daytona Beach, Florida, United States, 32114
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Jacksonville, Florida, United States, 32258
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Jacksonville, Florida, United States, 32216
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Jacksonville, Florida, United States, 32209
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Jacksonville, Florida, United States, 32216
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Jacksonville, Florida, United States, 32207
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Jacksonville Beach, Florida, United States, 32250
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Melbourne, Florida, United States, 32901
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Miami, Florida, United States, 33173
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Miami, Florida, United States, 33136
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Manhasset, New York, United States, 11030
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Massapequa, New York, United States, 11758
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Raleigh, North Carolina, United States, 27610
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Akron, Ohio, United States, 44304
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Columbus, Ohio, United States, 43214
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Lorain, Ohio, United States, 44053
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Sandusky, Ohio, United States, 44870
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Westlake, Ohio, United States, 44145
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Oklahoma City, Oklahoma, United States, 73109
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Camp Hill, Pennsylvania, United States, 17011
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Philadelphia, Pennsylvania, United States, 19141
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Philadelphia, Pennsylvania, United States, 19102
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Philadelphia, Pennsylvania, United States, 19140
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Pittsburgh, Pennsylvania, United States, 15213
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Sellersville, Pennsylvania, United States, 18960
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Wyomissing, Pennsylvania, United States, 19610
United States, South Carolina
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Charleston, South Carolina, United States, 29425
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Simpsonville, South Carolina, United States, 29681
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Spartanburg, South Carolina, United States, 29302
United States, Tennessee
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Johnson City, Tennessee, United States, 37604
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Johnson City, Tennessee, United States, 37604
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Amarillo, Texas, United States, 79106
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Grapevine, Texas, United States, 76051
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McKinney, Texas, United States, 75069
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Madison, Wisconsin, United States, 53715
Brazil
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Salvador, Bahia, Brazil, 41148-900
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Curitiba, Parana, Brazil, 80010-030
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Belo Horizonte - MG, Brazil, 30150-221
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Brasília - DF, Brazil, 70390-700
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Campinas, Brazil, 13060-803
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Niteroi, Brazil, 24020-350
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Passo Fundo - RS, Brazil, 99010-080
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Porto Alegre - RS, Brazil, 90020-090
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Porto Alegre - RS, Brazil, 90035-903
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Rio de Janeiro, Brazil, 22251-030
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Rio de Janeiro - RJ, Brazil, 22280-020
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Rio de Janeiro - RJ, Brazil, 22240-006
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Salvador - BA, Brazil, 41810-010
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São José, Brazil, 88103-460
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São Paulo - SP, Brazil, 05403-000
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São Paulo - SP, Brazil, 04012-180
Sponsors and Collaborators
Forest Laboratories
PPD
Investigators
Study Director: David B Bharucha, MD, PhD, FACC Forest Laboratories
  More Information

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00990327     History of Changes
Other Study ID Numbers: PGX-III-AP-001
Study First Received: October 2, 2009
Last Updated: April 27, 2012
Health Authority: United States: Food and Drug Administration
Brazil: Ministry of Health

Keywords provided by Forest Laboratories:
Coronary artery disease
Myocardial Perfusion Imaging

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Adenosine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on April 17, 2014