Clinical trial NCT00990327: Study of the Safety and Efficacy of Apadenoson for Detection of Myocardial Perfusion Defects Using SPECT MPI
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease
Myocardial Perfusion Imaging
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
Collaborators: name: PPD Development, LP
First posted: 2009-10-06
Enrollment: 863
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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 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. 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 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

Primary outcomes:
measure: Presence of myocardial perfusion defect as based on SPECT-MPI
timeFrame: Up to 2 hours after study drug administration in Period 1 and 2
Secondary outcomes:
measure: 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
timeFrame: 1 hour after Period 2 study drug administration
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Forest Investigative Site 152
state: Alabama
city: Mobile
country: United States
facility: Forest Investigative Site 250
state: Alabama
city: Phoenix
country: United States
facility: Forest Investigative Site 223
state: Arizona
city: Phoenix
country: United States
facility: Forest Investigative Site 191
state: Arizona
city: Jonesboro
country: United States
facility: Forest Investigative Site 230
state: Arkansas
city: Little Rock
country: United States
facility: Forest Investigative Site 153
state: Arkansas
city: La Mesa
country: United States
facility: Forest Investigative Site 108
state: California
city: Mission Viejo
country: United States
facility: Forest Investigative Site 111
state: California
city: Murrieta
country: United States
facility: Forest Investigative Site 234
state: California
city: Roseville
country: United States
facility: Forest Investigative Site 146
state: California
city: Sacramento
country: United States
facility: Forest Investigative Site 225
state: California
city: Sacramento
country: United States
facility: Forest Investigative Site 122
state: California
city: Santa Rosa
country: United States
facility: Forest Investigative Site 105
state: California
city: Walnut Creek
country: United States
facility: Forest Investigative Site 196
state: California
city: Hartford
country: United States
facility: Forest Investigative Site 132
state: Connecticut
city: Newark
country: United States
facility: Forest Investigative Site 102
state: Delaware
city: Daytona Beach
country: United States
facility: Forest Investigative Site 205
state: Florida
city: Edgewater
country: United States
facility: Forest Investigative Site 233
state: Florida
city: Gainesville
country: United States
facility: Forest Investigative Site 164
state: Florida
city: Jacksonville Beach
country: United States
facility: Forest Investigative Site 126
state: Florida
city: Jacksonville
country: United States
facility: Forest Investigative Site 120
state: Florida
city: Jacksonville
country: United States
facility: Forest Investigative Site 198
state: Florida
city: Jacksonville
country: United States
facility: Forest Investigative Site 118
state: Florida
city: Jacksonville
country: United States
facility: Forest Investigative Site 124
state: Florida
city: Jacksonville
country: United States
facility: Forest Investigative Site 125
state: Florida
city: Melbourne
country: United States
facility: Forest Investigative Site 180
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site 183
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site 106
state: Florida
city: Naples
country: United States
facility: Forest Investigative Site 201
state: Florida
city: Tampa
country: United States
facility: Forest Investigative Site 240
state: Florida
city: Wellington
country: United States
facility: Forest Investigative Site 238
state: Florida
city: Augusta
country: United States
facility: Forest Investigative Site 155
state: Georgia
city: Cumming
country: United States
facility: Forest Investigative Site 199
state: Georgia
city: Tucker
country: United States
facility: Forest Investigative Site 204
state: Georgia
city: Honolulu
country: United States
facility: Forest Investigative Site 116
state: Hawaii
city: Boise
country: United States
facility: Forest Investigative Site 137
state: Idaho
city: Boise
country: United States
facility: Forest Investigative Site 138
state: Idaho
city: Chicago
country: United States
facility: Forest Investigative Site 227
state: Illinois
city: Joliet
country: United States
facility: Forest Investigative Site 228
state: Illinois
city: Winfield
country: United States
facility: Forest Investigative Site 173
state: Illinois
city: Indianapolis
country: United States
facility: Forest Investigative Site 113
state: Indiana
city: Valparaiso
country: United States
facility: Forest Investigative Site 168
state: Indiana
city: West Des Moines
country: United States
facility: Forest Investigative Site 171
state: Iowa
city: Overland Park
country: United States
facility: Forest Investigative Site 133
state: Kansas
city: Crestview Hills
country: United States
facility: Forest Investigative Site 248
state: Kentucky
city: Owensboro
country: United States
facility: Forest Investigative Site 241
state: Kentucky
city: Alexandria
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facility: Forest Investigative Site 202
state: Louisiana
city: Covington
country: United States
facility: Forest Investigative Site 257
state: Louisiana
city: Auburn
country: United States
facility: Forest Investigative Site 114
state: Maine
city: Scarborough
country: United States
facility: Forest Investigative Site 107
state: Maine
city: South Portland
country: United States
facility: Forest Investigative Site 109
state: Maine
city: Baltimore
country: United States
facility: Forest Investigative Site 193
state: Maryland
city: Westminster
country: United States
facility: Forest investigative Site 197
state: Maryland
city: Detroit
country: United States
facility: Forest Investigative Site 143
state: Michigan
city: Petoskey
country: United States
facility: Forest Investigative Site 207
state: Michigan
city: Saint Louis Park
country: United States
facility: Forest Investigative Site 177
state: Minnesota
city: Tupelo
country: United States
facility: Forest Investigative Site 131
state: Mississippi
city: Kansas City
country: United States
facility: Forest Investigative Site 176
state: Missouri
city: St. Louis
country: United States
facility: Forest Investigative Site 159
state: Missouri
city: Missoula
country: United States
facility: Forest Investigative Site 188
state: Montana
city: Albany
country: United States
facility: Forest Investigative Site 115
state: New York
city: Buffalo
country: United States
facility: Forest Investigative Site 212
state: New York
city: Kingston
country: United States
facility: Forest Investigative Site 165
state: New York
city: Manhasset
country: United States
facility: Forest Investigative Site 224
state: New York
city: Massapequa
country: United States
facility: Forest Investigative Site 139
state: New York
city: Raleigh
country: United States
facility: Forest Investigative Site 208
state: North Carolina
city: Sanford
country: United States
facility: Forest Investigative Site 249
state: North Carolina
city: Fargo
country: United States
facility: Forest Investigative Site 214
state: North Dakota
city: Akron
country: United States
facility: Forest Investigative Site 235
state: Ohio
city: Columbus
country: United States
facility: Forest Investigative Site163
state: Ohio
city: Columbus
country: United States
facility: Forest Investigative Site 161
state: Ohio
city: Lorain
country: United States
facility: Forest Investigative Site 156
state: Ohio
city: Sandusky
country: United States
facility: Forest Investigative Site 185
state: Ohio
city: Westlake
country: United States
facility: Forest Investigative Site 101
state: Ohio
city: Oklahoma City
country: United States
facility: Forest Investigative Site 182
state: Oklahoma
city: Bend
country: United States
facility: Forest Investigative Site 190
state: Oregon
city: Portland
country: United States
facility: Forest Investigative Site 217
state: Oregon
city: Camp Hill
country: United States
facility: Forest Investigative Site 213
state: Pennsylvania
city: Philadelphia
country: United States
facility: Forest Investigative Site 154
state: Pennsylvania
city: Philadelphia
country: United States
facility: Forest Investigative Site 134
state: Pennsylvania
city: Philadelphia
country: United States
facility: Forest Investigative Site 218
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Forest Investigative Site 160
state: Pennsylvania
city: Sellersville
country: United States
facility: Forest Investigative Site 187
state: Pennsylvania
city: Wyomissing
country: United States
facility: Forest Investigative Site 117
state: Pennsylvania
city: Charleston
country: United States
facility: Forest Investigative Site 149
state: South Carolina
city: Simpsonville
country: United States
facility: Forest Investigative Site 172
state: South Carolina
city: Spartanburg
country: United States
facility: Forest Investigative Site 229
state: South Carolina
city: Johnson City
country: United States
facility: Forest Investigative Site 167
state: Tennessee
city: Johnson City
country: United States
facility: Forest Investigative Site 192
state: Tennessee
city: Amarillo
country: United States
facility: Forest Investigative Site 128
state: Texas
city: Grapevine
country: United States
facility: Forest Investigative Site 252
state: Texas
city: McKinney
country: United States
facility: Forest Investigative Site 200
state: Texas
city: Plano
country: United States
facility: Forest Investigative Site 181
state: Texas
city: San Antonio
country: United States
facility: Forest Investigative Site 253
state: Texas
city: Sugar Land
country: United States
facility: Forest Investigative Site 186
state: Texas
city: Tomball
country: United States
facility: Forest Investigative Site 231
state: Texas
city: Tomball
country: United States
facility: Forest Investigative Site 232
state: Texas
city: Provo
country: United States
facility: Forest Investigative Site 236
state: Utah
city: Charlottesville
country: United States
facility: Forest Investigative Site 210
state: Virginia
city: Roanoke
country: United States
facility: Forest Investigative Site 110
state: Virginia
city: Seattle
country: United States
facility: Forest Investigative Site 151
state: Washington
city: Spokane
country: United States
facility: Forest Investigative Site 142
state: Washington
city: Madison
country: United States
facility: Forest Investigative Site 144
state: Wisconsin
city: Salvador
country: Brazil
facility: Forest Investigative Site 306
state: Bahia
city: Curitiba
country: Brazil
facility: Forest Investigative Site 307
state: Parana
city: Belo Horizonte - MG
country: Brazil
facility: Forest Investigative Site 308
city: Brasília - DF
country: Brazil
facility: Forest Investigative Site 317
city: Campinas
country: Brazil
facility: Forest Investigative Site 311
city: Curitiba - PR
country: Brazil
facility: Forest Investigative Site 314
city: Curitiba
country: Brazil
facility: Forest Investigative Site 313
city: Curitiba
country: Brazil
facility: Forest Investigative Site 305
city: Niteroi
country: Brazil
facility: Forest Investigative Site 316
city: Passo Fundo - RS
country: Brazil
facility: Forest Investigative Site 309
city: Porto Alegre - RS
country: Brazil
facility: Forest Investigative Site 318
city: Porto Alegre - RS
country: Brazil
facility: Forest Investigative Site 310
city: Rio de Janeiro - RJ
country: Brazil
facility: Forest Investigative Site 319
city: Rio de Janeiro - RJ
country: Brazil
facility: Forest Investigative Site 304
city: Rio de Janeiro
country: Brazil
facility: Forest Investigative Site 315
city: Salvador - BA
country: Brazil
facility: Forest Investigative Site 301
city: São José
country: Brazil
facility: Forest Investigative Site 303
city: São Paulo - SP
country: Brazil
facility: Forest Investigative Site 302
city: São Paulo - SP
country: Brazil
facility: Forest Investigative Site 312
Study officials:
affiliation: Forest Laboratories
name: David B Bharucha, MD, PhD, FACC
role: STUDY_DIRECTOR
References: