Coronary Artery Disease Clinical Trial
— ASPECTOfficial 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)
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.
Status | Terminated |
Enrollment | 863 |
Est. completion date | April 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Brazil | Forest Investigative Site 308 | Belo Horizonte - MG | |
Brazil | Forest Investigative Site 317 | Brasília - DF | |
Brazil | Forest Investigative Site 311 | Campinas | |
Brazil | Forest Investigative Site 305 | Curitiba | |
Brazil | Forest Investigative Site 307 | Curitiba | Parana |
Brazil | Forest Investigative Site 313 | Curitiba | |
Brazil | Forest Investigative Site 314 | Curitiba - PR | |
Brazil | Forest Investigative Site 316 | Niteroi | |
Brazil | Forest Investigative Site 309 | Passo Fundo - RS | |
Brazil | Forest Investigative Site 310 | Porto Alegre - RS | |
Brazil | Forest Investigative Site 318 | Porto Alegre - RS | |
Brazil | Forest Investigative Site 315 | Rio de Janeiro | |
Brazil | Forest Investigative Site 304 | Rio de Janeiro - RJ | |
Brazil | Forest Investigative Site 319 | Rio de Janeiro - RJ | |
Brazil | Forest Investigative Site 306 | Salvador | Bahia |
Brazil | Forest Investigative Site 301 | Salvador - BA | |
Brazil | Forest Investigative Site 303 | São José | |
Brazil | Forest Investigative Site 302 | São Paulo - SP | |
Brazil | Forest Investigative Site 312 | São Paulo - SP | |
United States | Forest Investigative Site 235 | Akron | Ohio |
United States | Forest Investigative Site 115 | Albany | New York |
United States | Forest Investigative Site 202 | Alexandria | Louisiana |
United States | Forest Investigative Site 128 | Amarillo | Texas |
United States | Forest Investigative Site 114 | Auburn | Maine |
United States | Forest Investigative Site 155 | Augusta | Georgia |
United States | Forest Investigative Site 193 | Baltimore | Maryland |
United States | Forest Investigative Site 190 | Bend | Oregon |
United States | Forest Investigative Site 152 | Birmingham | Alabama |
United States | Forest Investigative Site 137 | Boise | Idaho |
United States | Forest Investigative Site 138 | Boise | Idaho |
United States | Forest Investigative Site 212 | Buffalo | New York |
United States | Forest Investigative Site 213 | Camp Hill | Pennsylvania |
United States | Forest Investigative Site 149 | Charleston | South Carolina |
United States | Forest Investigative Site 210 | Charlottesville | Virginia |
United States | Forest Investigative Site 227 | Chicago | Illinois |
United States | Forest Investigative Site 161 | Columbus | Ohio |
United States | Forest Investigative Site163 | Columbus | Ohio |
United States | Forest Investigative Site 257 | Covington | Louisiana |
United States | Forest Investigative Site 248 | Crestview Hills | Kentucky |
United States | Forest Investigative Site 199 | Cumming | Georgia |
United States | Forest Investigative Site 205 | Daytona Beach | Florida |
United States | Forest Investigative Site 143 | Detroit | Michigan |
United States | Forest Investigative Site 233 | Edgewater | Florida |
United States | Forest Investigative Site 214 | Fargo | North Dakota |
United States | Forest Investigative Site 164 | Gainesville | Florida |
United States | Forest Investigative Site 252 | Grapevine | Texas |
United States | Forest Investigative Site 132 | Hartford | Connecticut |
United States | Forest Investigative Site 116 | Honolulu | Hawaii |
United States | Forest Investigative Site 113 | Indianapolis | Indiana |
United States | Forest Investigative Site 118 | Jacksonville | Florida |
United States | Forest Investigative Site 120 | Jacksonville | Florida |
United States | Forest Investigative Site 124 | Jacksonville | Florida |
United States | Forest Investigative Site 125 | Jacksonville | Florida |
United States | Forest Investigative Site 198 | Jacksonville | Florida |
United States | Forest Investigative Site 126 | Jacksonville Beach | Florida |
United States | Forest Investigative Site 167 | Johnson City | Tennessee |
United States | Forest Investigative Site 192 | Johnson City | Tennessee |
United States | Forest Investigative Site 228 | Joliet | Illinois |
United States | Forest Investigative Site 230 | Jonesboro | Arkansas |
United States | Forest Investigative Site 176 | Kansas City | Missouri |
United States | Forest Investigative Site 165 | Kingston | New York |
United States | Forest Investigative Site 108 | La Mesa | California |
United States | Forest Investigative Site 153 | Little Rock | Arkansas |
United States | Forest Investigative Site 156 | Lorain | Ohio |
United States | Forest Investigative Site 144 | Madison | Wisconsin |
United States | Forest Investigative Site 224 | Manhasset | New York |
United States | Forest Investigative Site 139 | Massapequa | New York |
United States | Forest Investigative Site 200 | McKinney | Texas |
United States | Forest Investigative Site 180 | Melbourne | Florida |
United States | Forest Investigative Site 106 | Miami | Florida |
United States | Forest Investigative Site 183 | Miami | Florida |
United States | Forest Investigative Site 111 | Mission Viejo | California |
United States | Forest Investigative Site 188 | Missoula | Montana |
United States | Forest Investigative Site 250 | Mobile | Alabama |
United States | Forest Investigative Site 234 | Murrieta | California |
United States | Forest Investigative Site 201 | Naples | Florida |
United States | Forest Investigative Site 102 | Newark | Delaware |
United States | Forest Investigative Site 182 | Oklahoma City | Oklahoma |
United States | Forest Investigative Site 133 | Overland Park | Kansas |
United States | Forest Investigative Site 241 | Owensboro | Kentucky |
United States | Forest Investigative Site 207 | Petoskey | Michigan |
United States | Forest Investigative Site 134 | Philadelphia | Pennsylvania |
United States | Forest Investigative Site 154 | Philadelphia | Pennsylvania |
United States | Forest Investigative Site 218 | Philadelphia | Pennsylvania |
United States | Forest Investigative Site 191 | Phoenix | Arizona |
United States | Forest Investigative Site 223 | Phoenix | Arizona |
United States | Forest Investigative Site 160 | Pittsburgh | Pennsylvania |
United States | Forest Investigative Site 181 | Plano | Texas |
United States | Forest Investigative Site 217 | Portland | Oregon |
United States | Forest Investigative Site 236 | Provo | Utah |
United States | Forest Investigative Site 208 | Raleigh | North Carolina |
United States | Forest Investigative Site 110 | Roanoke | Virginia |
United States | Forest Investigative Site 146 | Roseville | California |
United States | Forest Investigative Site 122 | Sacramento | California |
United States | Forest Investigative Site 225 | Sacramento | California |
United States | Forest Investigative Site 177 | Saint Louis Park | Minnesota |
United States | Forest Investigative Site 253 | San Antonio | Texas |
United States | Forest Investigative Site 185 | Sandusky | Ohio |
United States | Forest Investigative Site 249 | Sanford | North Carolina |
United States | Forest Investigative Site 105 | Santa Rosa | California |
United States | Forest Investigative Site 107 | Scarborough | Maine |
United States | Forest Investigative Site 151 | Seattle | Washington |
United States | Forest Investigative Site 187 | Sellersville | Pennsylvania |
United States | Forest Investigative Site 172 | Simpsonville | South Carolina |
United States | Forest Investigative Site 109 | South Portland | Maine |
United States | Forest Investigative Site 229 | Spartanburg | South Carolina |
United States | Forest Investigative Site 142 | Spokane | Washington |
United States | Forest Investigative Site 159 | St. Louis | Missouri |
United States | Forest Investigative Site 186 | Sugar Land | Texas |
United States | Forest Investigative Site 240 | Tampa | Florida |
United States | Forest Investigative Site 231 | Tomball | Texas |
United States | Forest Investigative Site 232 | Tomball | Texas |
United States | Forest Investigative Site 204 | Tucker | Georgia |
United States | Forest Investigative Site 131 | Tupelo | Mississippi |
United States | Forest Investigative Site 168 | Valparaiso | Indiana |
United States | Forest Investigative Site 196 | Walnut Creek | California |
United States | Forest Investigative Site 238 | Wellington | Florida |
United States | Forest Investigative Site 171 | West Des Moines | Iowa |
United States | Forest Investigative Site 101 | Westlake | Ohio |
United States | Forest investigative Site 197 | Westminster | Maryland |
United States | Forest Investigative Site 173 | Winfield | Illinois |
United States | Forest Investigative Site 117 | Wyomissing | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Forest Laboratories | PPD |
United States, Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Presence of myocardial perfusion defect as based on SPECT-MPI | Up to 2 hours after study drug administration in Period 1 and 2 | Yes | |
Secondary | 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 | 1 hour after Period 2 study drug administration | No |
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