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

April 27, 2012 updated by: Forest Laboratories

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

863

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Belo Horizonte - MG, Brazil, 30150-221
        • Forest Investigative Site 308
      • Brasília - DF, Brazil, 70390-700
        • Forest Investigative Site 317
      • Campinas, Brazil, 13060-803
        • Forest Investigative Site 311
      • Curitiba, Brazil, 80050-010
        • Forest Investigative Site 313
      • Curitiba, Brazil, 83430-000
        • Forest Investigative Site 305
      • Curitiba - PR, Brazil, 80320-320
        • Forest Investigative Site 314
      • Niteroi, Brazil, 24020-350
        • Forest Investigative Site 316
      • Passo Fundo - RS, Brazil, 99010-080
        • Forest Investigative Site 309
      • Porto Alegre - RS, Brazil, 90020-090
        • Forest Investigative Site 318
      • Porto Alegre - RS, Brazil, 90035-903
        • Forest Investigative Site 310
      • Rio de Janeiro, Brazil, 22251-030
        • Forest Investigative Site 315
      • Rio de Janeiro - RJ, Brazil, 22240-006
        • Forest Investigative Site 319
      • Rio de Janeiro - RJ, Brazil, 22280-020
        • Forest Investigative Site 304
      • Salvador - BA, Brazil, 41810-010
        • Forest Investigative Site 301
      • São José, Brazil, 88103-460
        • Forest Investigative Site 303
      • São Paulo - SP, Brazil, 04012-180
        • Forest Investigative Site 302
      • São Paulo - SP, Brazil, 05403-000
        • Forest Investigative Site 312
    • Bahia
      • Salvador, Bahia, Brazil, 41148-900
        • Forest Investigative Site 306
    • Parana
      • Curitiba, Parana, Brazil, 80010-030
        • Forest Investigative Site 307
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Forest Investigative Site 152
      • Mobile, Alabama, United States, 36608
        • Forest Investigative Site 250
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Forest Investigative Site 223
      • Phoenix, Arizona, United States, 85020
        • Forest Investigative Site 191
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Forest Investigative Site 230
      • Little Rock, Arkansas, United States, 72204
        • Forest Investigative Site 153
    • California
      • La Mesa, California, United States, 91942
        • Forest Investigative Site 108
      • Mission Viejo, California, United States, 92691
        • Forest Investigative Site 111
      • Murrieta, California, United States, 92562
        • Forest Investigative Site 234
      • Roseville, California, United States, 95661
        • Forest Investigative Site 146
      • Sacramento, California, United States, 95816
        • Forest Investigative Site 225
      • Sacramento, California, United States, 95825
        • Forest Investigative Site 122
      • Santa Rosa, California, United States, 95405
        • Forest Investigative Site 105
      • Walnut Creek, California, United States, 94598
        • Forest Investigative Site 196
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Forest Investigative Site 132
    • Delaware
      • Newark, Delaware, United States, 19713
        • Forest Investigative Site 102
    • Florida
      • Daytona Beach, Florida, United States, 32114
        • Forest Investigative Site 205
      • Edgewater, Florida, United States, 32141
        • Forest Investigative Site 233
      • Gainesville, Florida, United States, 32605
        • Forest Investigative Site 164
      • Jacksonville, Florida, United States, 32207
        • Forest Investigative Site 120
      • Jacksonville, Florida, United States, 32209
        • Forest Investigative Site 198
      • Jacksonville, Florida, United States, 32216
        • Forest Investigative Site 118
      • Jacksonville, Florida, United States, 32216
        • Forest Investigative Site 124
      • Jacksonville, Florida, United States, 32258
        • Forest Investigative Site 125
      • Jacksonville Beach, Florida, United States, 32250
        • Forest Investigative Site 126
      • Melbourne, Florida, United States, 32901
        • Forest Investigative Site 180
      • Miami, Florida, United States, 33136
        • Forest Investigative Site 183
      • Miami, Florida, United States, 33173
        • Forest Investigative Site 106
      • Naples, Florida, United States, 34119
        • Forest Investigative Site 201
      • Tampa, Florida, United States, 33609
        • Forest Investigative Site 240
      • Wellington, Florida, United States, 33449
        • Forest Investigative Site 238
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Forest Investigative Site 155
      • Cumming, Georgia, United States, 30041
        • Forest Investigative Site 199
      • Tucker, Georgia, United States, 30084
        • Forest Investigative Site 204
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Forest Investigative Site 116
    • Idaho
      • Boise, Idaho, United States, 83712
        • Forest Investigative Site 137
      • Boise, Idaho, United States, 83712
        • Forest Investigative Site 138
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Forest Investigative Site 227
      • Joliet, Illinois, United States, 60435
        • Forest Investigative Site 228
      • Winfield, Illinois, United States, 60190
        • Forest Investigative Site 173
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Forest Investigative Site 113
      • Valparaiso, Indiana, United States, 46383
        • Forest Investigative Site 168
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Forest Investigative Site 171
    • Kansas
      • Overland Park, Kansas, United States, 66209
        • Forest Investigative Site 133
    • Kentucky
      • Crestview Hills, Kentucky, United States, 41017
        • Forest Investigative Site 248
      • Owensboro, Kentucky, United States, 42303
        • Forest Investigative Site 241
    • Louisiana
      • Alexandria, Louisiana, United States, 71301
        • Forest Investigative Site 202
      • Covington, Louisiana, United States, 70433
        • Forest Investigative Site 257
    • Maine
      • Auburn, Maine, United States, 04210
        • Forest Investigative Site 114
      • Scarborough, Maine, United States, 04074
        • Forest Investigative Site 107
      • South Portland, Maine, United States, 04106
        • Forest Investigative Site 109
    • Maryland
      • Baltimore, Maryland, United States, 21208
        • Forest Investigative Site 193
      • Westminster, Maryland, United States, 21157
        • Forest Investigative Site 197
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Forest Investigative Site 143
      • Petoskey, Michigan, United States, 49770
        • Forest Investigative Site 207
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55416
        • Forest Investigative Site 177
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Forest Investigative Site 131
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Forest Investigative Site 176
      • St. Louis, Missouri, United States, 63110
        • Forest Investigative Site 159
    • Montana
      • Missoula, Montana, United States, 59802
        • Forest Investigative Site 188
    • New York
      • Albany, New York, United States, 12205
        • Forest Investigative Site 115
      • Buffalo, New York, United States, 14215
        • Forest Investigative Site 212
      • Kingston, New York, United States, 12401
        • Forest Investigative Site 165
      • Manhasset, New York, United States, 11030
        • Forest Investigative Site 224
      • Massapequa, New York, United States, 11758
        • Forest Investigative Site 139
    • North Carolina
      • Raleigh, North Carolina, United States, 27610
        • Forest Investigative Site 208
      • Sanford, North Carolina, United States, 27330
        • Forest Investigative Site 249
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • Forest Investigative Site 214
    • Ohio
      • Akron, Ohio, United States, 44304
        • Forest Investigative Site 235
      • Columbus, Ohio, United States, 43210
        • Forest Investigative Site163
      • Columbus, Ohio, United States, 43214
        • Forest Investigative Site 161
      • Lorain, Ohio, United States, 44053
        • Forest Investigative Site 156
      • Sandusky, Ohio, United States, 44870
        • Forest Investigative Site 185
      • Westlake, Ohio, United States, 44145
        • Forest Investigative Site 101
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73109
        • Forest Investigative Site 182
    • Oregon
      • Bend, Oregon, United States, 97701
        • Forest Investigative Site 190
      • Portland, Oregon, United States, 97239
        • Forest Investigative Site 217
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
        • Forest Investigative Site 213
      • Philadelphia, Pennsylvania, United States, 19102
        • Forest Investigative Site 154
      • Philadelphia, Pennsylvania, United States, 19140
        • Forest Investigative Site 134
      • Philadelphia, Pennsylvania, United States, 19141
        • Forest Investigative Site 218
      • Pittsburgh, Pennsylvania, United States, 15213
        • Forest Investigative Site 160
      • Sellersville, Pennsylvania, United States, 18960
        • Forest Investigative Site 187
      • Wyomissing, Pennsylvania, United States, 19610
        • Forest Investigative Site 117
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Forest Investigative Site 149
      • Simpsonville, South Carolina, United States, 29681
        • Forest Investigative Site 172
      • Spartanburg, South Carolina, United States, 29302
        • Forest Investigative Site 229
    • Tennessee
      • Johnson City, Tennessee, United States, 37604
        • Forest Investigative Site 167
      • Johnson City, Tennessee, United States, 37604
        • Forest Investigative Site 192
    • Texas
      • Amarillo, Texas, United States, 79106
        • Forest Investigative Site 128
      • Grapevine, Texas, United States, 76051
        • Forest Investigative Site 252
      • McKinney, Texas, United States, 75069
        • Forest Investigative Site 200
      • Plano, Texas, United States, 75024
        • Forest Investigative Site 181
      • San Antonio, Texas, United States, 78215
        • Forest Investigative Site 253
      • Sugar Land, Texas, United States, 77479
        • Forest Investigative Site 186
      • Tomball, Texas, United States, 77375
        • Forest Investigative Site 231
      • Tomball, Texas, United States, 77375
        • Forest Investigative Site 232
    • Utah
      • Provo, Utah, United States, 84604
        • Forest Investigative Site 236
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Forest Investigative Site 210
      • Roanoke, Virginia, United States, 24014
        • Forest Investigative Site 110
    • Washington
      • Seattle, Washington, United States, 98195
        • Forest Investigative Site 151
      • Spokane, Washington, United States, 99204
        • Forest Investigative Site 142
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
        • Forest Investigative Site 144

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Adenoscan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Up to 2 hours after study drug administration in Period 1 and 2

Secondary Outcome Measures

Outcome Measure
Time Frame
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
1 hour after Period 2 study drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forest Laboratories

Collaborators

PPD

Investigators

  • Study Director: David B Bharucha, MD, PhD, FACC, Forest Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

October 2, 2009

First Submitted That Met QC Criteria

October 5, 2009

First Posted (Estimate)

October 6, 2009

Study Record Updates

Last Update Posted (Estimate)

May 1, 2012

Last Update Submitted That Met QC Criteria

April 27, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PGX-III-AP-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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