Study of the Safety and Efficacy of Apadenoson for Detection of Myocardial Perfusion Defects Using SPECT MPI (ASPECT2)

April 27, 2012 updated by: Forest Laboratories

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)

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.

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. 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.

Study Type

Interventional

Enrollment (Actual)

197

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

  • Argentina
      • Buenos Aires, Argentina, 1177AEJ
        • Forest Investigative Site 209
      • Ciudad Autonoma de Buenos Aires, Argentina, 1201
        • Forest Investigative Site 212
      • Cordoba, Argentina, X5000JJS
        • Forest Investigative Site 207
      • Cordoba, Argentina, X5003FGG
        • Forest Investigative Site 203
      • Córdoba, Argentina, X5000AAX
        • Forest Investigative Site 211
      • Godoy Cruz, Argentina, M5501AAJ
        • Forest Investigative Site 202
      • Godoy Cruz,, Argentina, M5501AAJ
        • Forest Investigative Site 201
      • La Plata, Argentina, B1925XAC
        • Forest Investigative Site 214
      • Mar del Plata, Argentina, B7600FZD
        • Forest Investigative Site 210
      • San Isidro, Argentina, B1642CAD
        • Forest Investigative Site 213
      • Santa fe, Argentina, S3000AOL
        • Forest Investigative Site 206
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1122AAL
        • Forest Investigative Site 205
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000DIF
        • Forest Investigative Site 208
    • Santa Fé
      • Rosario, Santa Fé, Argentina, S2000ODA
        • Forest Investigative Site 204
  • Belgium
      • Aalst, Belgium, 9300
        • Forest Investigative Site 501
      • Bruxelles, Belgium, 1200
        • Forest Investigative Site 503
  • Brazil
      • Belo Horizonte, Brazil, 30130-100
        • Forest Investigative Site 307
      • Belo Horizonte, Brazil, 30140-000
        • Forest Investigative Site 308
      • Curitiba, Brazil, 80050-010
        • Forest Investigatie Site 301
      • Goiânia, Brazil, 74823-470
        • Forest Investigative Site 306
      • Maceió, Brazil, 57021-500
        • Forest Investigative Site 310
      • Porto Alegre, Brazil, 90610-000
        • Forest Investigative Site 302
      • Recife, Brazil, 52010-010
        • Forest Investigative Site 304
      • Rio de Janeiro, Brazil, 22251-050
        • Forest Investigative Site 315
      • Rio de Janeiro, Brazil, 22640-102
        • Forest Investigative Site 311
      • Salvador, Brazil, 40050-410
        • Forest Investigative Site 303
      • Sao Paulo, Brazil, 04012-180
        • Forest Investigative Site 313
      • São José do Rio Preto, Brazil, 15015-205
        • Forest Investigative Site 305
      • São Paulo, Brazil, 05403-000
        • Forest Investigative Site 316
    • Parana
      • Curitiba, Parana, Brazil, 80010-030
        • Forest Investigative Site 314
    • Paraná
      • Curitiba, Paraná, Brazil, 80320-320
        • Forest Investigative Site 312
    • São Paulo
      • São José do Rio Preto, São Paulo, Brazil, 15015-210
        • Forest Investigative Site 309
  • Netherlands
      • Amsterdam, Netherlands, 1061 AE
        • Forest Investigative Site 407
      • Delft, Netherlands, 2625 AD
        • Forest Investigative Site 405
      • Doetinchem, Netherlands, 7009 BL
        • Forest Investigative Site 401
      • Hengelo, Netherlands, 7555 DL
        • Forest Investigative Site 408
      • Hoogeveen, Netherlands, 7909 AA
        • Forest Investigative Site 404
      • Maastricht, Netherlands, 6229 HX
        • Forest Investigative Site 406
      • Rotterdam, Netherlands, 3045 PM
        • Forest Investigative Site 409
    • Bleuland
      • Gouda, Bleuland, Netherlands, 2803 HH
        • Forest Investigative Site 402
    • Lukas
      • Apeldoorn, Lukas, Netherlands, 7334 DZ
        • Forest Investigative Site 403
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Forest Investigative Site 138
      • Phoenix, Arizona, United States, 85020
        • Forest Investigative Site 146
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • Forest Investigative Site 113
    • California
      • Beverly Hills, California, United States, 90210
        • Forest Investigative Site 148
      • Los Angeles, California, United States, 90048
        • Forest Investigative Site 154
      • Mission Viejo, California, United States, 92691
        • Forest Investigative Site 131
    • Colorado
      • Denver, Colorado, United States, 80206
        • Forest Investigative Site 156
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Forest Investigative Site 108
    • Delaware
      • Newark, Delaware, United States, 19713
        • Forest Investigative Site 111
    • Florida
      • Clearwater, Florida, United States, 33756
        • Forest Investigative Site 101
      • Daytona Beach, Florida, United States, 32117
        • Forest Investigative Site 163
      • Edgewater, Florida, United States, 32141
        • Forest Investigative Site 135
      • Inverness, Florida, United States, 34452
        • Forest Investigative Site 102
      • Jacksonville, Florida, United States, 32209
        • Forest Investigative Site 151
      • Melbourne, Florida, United States, 32901
        • Forest Investigative Site 105
      • Melbourne, Florida, United States, 32901
        • Forest Investigative Site 143
      • Miami, Florida, United States, 33136
        • Forest Investigative Site 137
      • Miami, Florida, United States, 33173
        • Forest Investigative Site 103
      • Naples, Florida, United States, 34119
        • Forest Investigative Site 123
      • Safety Harbor, Florida, United States, 34695
        • Forest Investigative Site 161
    • Georgia
      • Cumming, Georgia, United States, 30041
        • Forest Investigative Site 118
      • Tucker, Georgia, United States, 30084
        • Forest Investigative Site 119
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Forest Investigative Site 166
      • Hammond, Louisiana, United States, 70403
        • Forest Investigative Site 109
      • Slidell, Louisiana, United States, 70458
        • Forest Investigative Site 122
    • Maine
      • Auburn, Maine, United States, 04210
        • Forest Investigative Site 121
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Forest Investigative Site 124
      • Hollywood, Maryland, United States, 20636
        • Forest Investigative Site 149
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Forest Investigative Site 104
      • Detroit, Michigan, United States, 48202
        • Forest Investigative Site 134
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Forest Investigative Site 159
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • Forest Investigative Site 142
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Forest Investigative Site 162
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Forest Investigative Site 125
    • New York
      • New York, New York, United States, 10032
        • Forest Investigative Site 110
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
        • Forest Investigative Site 153
      • Pittsburgh, Pennsylvania, United States, 15213
        • Forest Investigative Site 152
      • Wyomissing, Pennsylvania, United States, 19610
        • Forest Investigative Site 120
    • Tennessee
      • Johnson City,, Tennessee, United States, 37604
        • Forest Investigative Site 145
      • Nashville, Tennessee, United States, 37203
        • Forest Investigative Site 140
    • Texas
      • Houston, Texas, United States, 77024
        • Forest Investigative Site 107
      • Houston, Texas, United States, 77070
        • Forest Investigative Site 129
      • Plano, Texas, United States, 75024
        • Forest Investigative Site 115
      • Tomball, Texas, United States, 77375
        • Forest Investigative Site 150
    • Utah
      • Provo, Utah, United States, 84604
        • 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:

  • 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 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
Drug: Apadenoson SPECT-MPI
Apadenoson single bolus IV injection 100 or 150 ug
Other Names:
  • BMS068645
  • 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 the active comparator: adenosine.
Drug: Apadenoson SPECT-MPI
Apadenoson single bolus IV injection 100 or 150 ug
Other Names:
  • BMS068645
  • 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 based on SPECT-MPI
Time Frame: Up to 2 hours after study drug administration in Period 1 and Period 2
Up to 2 hours after study drug administration in Period 1 and Period 2

Secondary Outcome Measures

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

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

August 1, 2011

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

March 4, 2011

First Submitted That Met QC Criteria

March 10, 2011

First Posted (Estimate)

March 11, 2011

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-002

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.

Clinical Trials on Coronary Artery Disease

Clinical Trials on Apadenoson SPECT-MPI

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe