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

Phase 3

Terminated

Conditions: Coronary Artery Disease

Interventions: Drug: Apadenoson SPECT-MPI
Drug: Adenosine SPECT-MPI

Registration Number: NCT01313572

Lead Sponsor: Forest Laboratories

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 197

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Adenosine	Apadenoson SPECT-MPI	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.
Apadenoson	Apadenoson SPECT-MPI	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
Apadenoson	Adenosine SPECT-MPI	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
Adenosine	Adenosine SPECT-MPI	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.

Primary Outcome Measures

Name	Time	Method
Presence of myocardial perfusion defect based on SPECT-MPI	Up to 2 hours after study drug administration in Period 1 and Period 2

Secondary Outcome Measures

Name	Time	Method
Incidence and subject rated intensity of most commonly reported side effects associated with use of adenosine compared to apadenoson in SPECT-MPI	Up to 2 hours after administration of study drug in Period 2

Trial Locations

Locations (86): Forest Investigative Site 162
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New Brunswick, New Jersey, United States
Forest Investigative Site 143
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Melbourne, Florida, United States
Forest Investigative Site 308
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Belo Horizonte, Brazil
Forest Investigatie Site 301
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Curitiba, Brazil
Forest Investigative Site 163
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Daytona Beach, Florida, United States
Forest Investigative Site 312
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Curitiba, Paraná, Brazil
Forest Investigative Site 105
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Melbourne, Florida, United States
Forest Investigative Site 205
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Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Forest Investigative Site 208
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Rosario, Santa Fe, Argentina
Forest Investigative Site 310
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Maceió, Brazil
Forest Investigative Site 304
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Recife, Brazil
Forest Investigative Site 315
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Rio de Janeiro, Brazil
Forest Investigative Site 303
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Salvador, Brazil
Forest Investigative Site 313
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Sao Paulo, Brazil
Forest Investigative Site 305
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São José do Rio Preto, Brazil
Forest Investigative Site 316
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São Paulo, Brazil
Forest Investigative Site 403
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Apeldoorn, Lukas, Netherlands
Forest Investigative Site 401
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Doetinchem, Netherlands
Forest Investigative Site 408
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Hengelo, Netherlands
Forest Investigative Site 404
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Hoogeveen, Netherlands
Forest Investigative Site 409
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Rotterdam, Netherlands
Forest Investigative Site 146
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Phoenix, Arizona, United States
Forest Investigative Site 107
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Houston, Texas, United States
Forest Investigative Site 138
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Phoenix, Arizona, United States
Forest Investigative Site 137
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Miami, Florida, United States
Forest Investigative Site 103
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Miami, Florida, United States
Forest Investigative Site 134
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Detroit, Michigan, United States
Forest Investigative Site 152
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Pittsburgh, Pennsylvania, United States
Forest Investigative Site 159
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Rochester, Minnesota, United States
Forest Investigative Site 129
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Houston, Texas, United States
Forest Investigative Site 154
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Los Angeles, California, United States
Forest Investigative Site 135
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Edgewater, Florida, United States
Forest Investigative Site 307
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Belo Horizonte, Brazil
Forest Investigative Site 306
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Goiânia, Brazil
Forest Investigative Site 302
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Porto Alegre, Brazil
Forest Investigative Site 309
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São José do Rio Preto, São Paulo, Brazil
Forest Investigative Site 131
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Mission Viejo, California, United States
Forest Investigative Site 101
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Clearwater, Florida, United States
Forest Investigative Site 113
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Little Rock, Arkansas, United States
Forest Investigative Site 148
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Beverly Hills, California, United States
Forest Investigative Site 108
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New Haven, Connecticut, United States
Forest Investigative Site 503
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Bruxelles, Belgium
Forest Investigative Site 161
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Safety Harbor, Florida, United States
Forest Investigative Site 156
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Denver, Colorado, United States
Forest Investigative Site 501
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Aalst, Belgium
Forest Investigative Site 104
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Detroit, Michigan, United States
Forest Investigative Site 402
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Gouda, Bleuland, Netherlands
Forest Investigative Site 125
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Albuquerque, New Mexico, United States
Forest Investigative Site 115
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Plano, Texas, United States
Forest Investigative Site 406
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Maastricht, Netherlands
Forest Investigative Site 314
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Curitiba, Parana, Brazil
Forest Investigative Site 311
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Rio de Janeiro, Brazil
Forest Investigative Site 407
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Amsterdam, Netherlands
Forest Investigative Site 405
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Delft, Netherlands
Forest Investigative Site 151
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Jacksonville, Florida, United States
Forest Investigative Site 111
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Newark, Delaware, United States
Forest Investigative Site 102
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Inverness, Florida, United States
Forest Investigative Site 123
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Naples, Florida, United States
Forest Investigative Site 118
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Cumming, Georgia, United States
Forest Investigative Site 119
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Tucker, Georgia, United States
Forest Investigative Site 124
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Annapolis, Maryland, United States
Forest Investigative Site 109
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Hammond, Louisiana, United States
Forest Investigative Site 121
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Auburn, Maine, United States
Forest Investigative Site 166
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Covington, Louisiana, United States
Forest Investigative Site 122
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Slidell, Louisiana, United States
Forest Investigative Site 149
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Hollywood, Maryland, United States
Forest Investigative Site 110
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New York, New York, United States
Forest Investigative Site 153
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Camp Hill, Pennsylvania, United States
Forest Investigative Site 142
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Kansas City, Missouri, United States
Forest Investigative Site 120
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Wyomissing, Pennsylvania, United States
Forest Investigative Site 145
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Johnson City,, Tennessee, United States
Forest Investigative Site 204
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Rosario, Santa Fé, Argentina
Forest Investigative Site 150
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Tomball, Texas, United States
Forest Investigative Site 140
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Nashville, Tennessee, United States
Forest Investigative Site 144
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Provo, Utah, United States
Forest Investigative Site 209
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Buenos Aires, Argentina
Forest Investigative Site 212
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Ciudad Autonoma de Buenos Aires, Argentina
Forest Investigative Site 201
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Godoy Cruz,, Argentina
Forest Investigative Site 207
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Cordoba, Argentina
Forest Investigative Site 211
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Córdoba, Argentina
Forest Investigative Site 203
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Cordoba, Argentina
Forest Investigative Site 214
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La Plata, Argentina
Forest Investigative Site 202
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Godoy Cruz, Argentina
Forest Investigative Site 210
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Mar del Plata, Argentina
Forest Investigative Site 213
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San Isidro, Argentina
Forest Investigative Site 206
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Santa fe, Argentina