Clinical trial NCT01313572: Study of the Safety and Efficacy of Apadenoson for Detection of Myocardial Perfusion Defects Using SPECT MPI
Official title: 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)
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: 2011-03-11
Enrollment: 197
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 (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.

Eligibility criteria: 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

Primary outcomes:
measure: Presence of myocardial perfusion defect based on SPECT-MPI
timeFrame: Up to 2 hours after study drug administration in Period 1 and Period 2
Secondary outcomes:
measure: Incidence and subject rated intensity of most commonly reported side effects associated with use of adenosine compared to apadenoson in SPECT-MPI
timeFrame: Up to 2 hours after administration of study drug in Period 2
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Forest Investigative Site 138
state: Arizona
city: Phoenix
country: United States
facility: Forest Investigative Site 146
state: Arizona
city: Little Rock
country: United States
facility: Forest Investigative Site 113
state: Arkansas
city: Beverly Hills
country: United States
facility: Forest Investigative Site 148
state: California
city: Los Angeles
country: United States
facility: Forest Investigative Site 154
state: California
city: Mission Viejo
country: United States
facility: Forest Investigative Site 131
state: California
city: Denver
country: United States
facility: Forest Investigative Site 156
state: Colorado
city: New Haven
country: United States
facility: Forest Investigative Site 108
state: Connecticut
city: Newark
country: United States
facility: Forest Investigative Site 111
state: Delaware
city: Clearwater
country: United States
facility: Forest Investigative Site 101
state: Florida
city: Daytona Beach
country: United States
facility: Forest Investigative Site 163
state: Florida
city: Edgewater
country: United States
facility: Forest Investigative Site 135
state: Florida
city: Inverness
country: United States
facility: Forest Investigative Site 102
state: Florida
city: Jacksonville
country: United States
facility: Forest Investigative Site 151
state: Florida
city: Melbourne
country: United States
facility: Forest Investigative Site 105
state: Florida
city: Melbourne
country: United States
facility: Forest Investigative Site 143
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site 137
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site 103
state: Florida
city: Naples
country: United States
facility: Forest Investigative Site 123
state: Florida
city: Safety Harbor
country: United States
facility: Forest Investigative Site 161
state: Florida
city: Cumming
country: United States
facility: Forest Investigative Site 118
state: Georgia
city: Tucker
country: United States
facility: Forest Investigative Site 119
state: Georgia
city: Covington
country: United States
facility: Forest Investigative Site 166
state: Louisiana
city: Hammond
country: United States
facility: Forest Investigative Site 109
state: Louisiana
city: Slidell
country: United States
facility: Forest Investigative Site 122
state: Louisiana
city: Auburn
country: United States
facility: Forest Investigative Site 121
state: Maine
city: Annapolis
country: United States
facility: Forest Investigative Site 124
state: Maryland
city: Hollywood
country: United States
facility: Forest Investigative Site 149
state: Maryland
city: Detroit
country: United States
facility: Forest Investigative Site 104
state: Michigan
city: Detroit
country: United States
facility: Forest Investigative Site 134
state: Michigan
city: Rochester
country: United States
facility: Forest Investigative Site 159
state: Minnesota
city: Kansas City
country: United States
facility: Forest Investigative Site 142
state: Missouri
city: New Brunswick
country: United States
facility: Forest Investigative Site 162
state: New Jersey
city: Albuquerque
country: United States
facility: Forest Investigative Site 125
state: New Mexico
city: New York
country: United States
facility: Forest Investigative Site 110
state: New York
city: Camp Hill
country: United States
facility: Forest Investigative Site 153
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Forest Investigative Site 152
state: Pennsylvania
city: Wyomissing
country: United States
facility: Forest Investigative Site 120
state: Pennsylvania
city: Johnson City,
country: United States
facility: Forest Investigative Site 145
state: Tennessee
city: Nashville
country: United States
facility: Forest Investigative Site 140
state: Tennessee
city: Houston
country: United States
facility: Forest Investigative Site 107
state: Texas
city: Houston
country: United States
facility: Forest Investigative Site 129
state: Texas
city: Plano
country: United States
facility: Forest Investigative Site 115
state: Texas
city: Tomball
country: United States
facility: Forest Investigative Site 150
state: Texas
city: Provo
country: United States
facility: Forest Investigative Site 144
state: Utah
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Forest Investigative Site 205
state: Buenos Aires
city: Rosario
country: Argentina
facility: Forest Investigative Site 208
state: Santa Fe
city: Rosario
country: Argentina
facility: Forest Investigative Site 204
state: Santa Fé
city: Buenos Aires
country: Argentina
facility: Forest Investigative Site 209
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Forest Investigative Site 212
city: Cordoba
country: Argentina
facility: Forest Investigative Site 207
city: Cordoba
country: Argentina
facility: Forest Investigative Site 203
city: Córdoba
country: Argentina
facility: Forest Investigative Site 211
city: Godoy Cruz,
country: Argentina
facility: Forest Investigative Site 201
city: Godoy Cruz
country: Argentina
facility: Forest Investigative Site 202
city: La Plata
country: Argentina
facility: Forest Investigative Site 214
city: Mar del Plata
country: Argentina
facility: Forest Investigative Site 210
city: San Isidro
country: Argentina
facility: Forest Investigative Site 213
city: Santa fe
country: Argentina
facility: Forest Investigative Site 206
city: Aalst
country: Belgium
facility: Forest Investigative Site 501
city: Bruxelles
country: Belgium
facility: Forest Investigative Site 503
city: Curitiba
country: Brazil
facility: Forest Investigative Site 314
state: Parana
city: Curitiba
country: Brazil
facility: Forest Investigative Site 312
state: Paraná
city: São José do Rio Preto
country: Brazil
facility: Forest Investigative Site 309
state: São Paulo
city: Belo Horizonte
country: Brazil
facility: Forest Investigative Site 307
city: Belo Horizonte
country: Brazil
facility: Forest Investigative Site 308
city: Curitiba
country: Brazil
facility: Forest Investigatie Site 301
city: Goiânia
country: Brazil
facility: Forest Investigative Site 306
city: Maceió
country: Brazil
facility: Forest Investigative Site 310
city: Porto Alegre
country: Brazil
facility: Forest Investigative Site 302
city: Recife
country: Brazil
facility: Forest Investigative Site 304
city: Rio de Janeiro
country: Brazil
facility: Forest Investigative Site 315
city: Rio de Janeiro
country: Brazil
facility: Forest Investigative Site 311
city: Salvador
country: Brazil
facility: Forest Investigative Site 303
city: Sao Paulo
country: Brazil
facility: Forest Investigative Site 313
city: São José do Rio Preto
country: Brazil
facility: Forest Investigative Site 305
city: São Paulo
country: Brazil
facility: Forest Investigative Site 316
city: Gouda
country: Netherlands
facility: Forest Investigative Site 402
state: Bleuland
city: Apeldoorn
country: Netherlands
facility: Forest Investigative Site 403
state: Lukas
city: Amsterdam
country: Netherlands
facility: Forest Investigative Site 407
city: Delft
country: Netherlands
facility: Forest Investigative Site 405
city: Doetinchem
country: Netherlands
facility: Forest Investigative Site 401
city: Hengelo
country: Netherlands
facility: Forest Investigative Site 408
city: Hoogeveen
country: Netherlands
facility: Forest Investigative Site 404
city: Maastricht
country: Netherlands
facility: Forest Investigative Site 406
city: Rotterdam
country: Netherlands
facility: Forest Investigative Site 409
Study officials:
affiliation: Forest Laboratories
name: David B Bharucha, MD, PhD, FACC
role: STUDY_DIRECTOR
References: