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

Primary Purpose

Coronary Artery Disease

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Apadenoson SPECT-MPI
Adenosine SPECT-MPI
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, Myocardial Perfusion Imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Forest Investigative Site 138
  • Forest Investigative Site 146
  • Forest Investigative Site 113
  • Forest Investigative Site 148
  • Forest Investigative Site 154
  • Forest Investigative Site 131
  • Forest Investigative Site 156
  • Forest Investigative Site 108
  • Forest Investigative Site 111
  • Forest Investigative Site 101
  • Forest Investigative Site 163
  • Forest Investigative Site 135
  • Forest Investigative Site 102
  • Forest Investigative Site 151
  • Forest Investigative Site 105
  • Forest Investigative Site 143
  • Forest Investigative Site 137
  • Forest Investigative Site 103
  • Forest Investigative Site 123
  • Forest Investigative Site 161
  • Forest Investigative Site 118
  • Forest Investigative Site 119
  • Forest Investigative Site 166
  • Forest Investigative Site 109
  • Forest Investigative Site 122
  • Forest Investigative Site 121
  • Forest Investigative Site 124
  • Forest Investigative Site 149
  • Forest Investigative Site 104
  • Forest Investigative Site 134
  • Forest Investigative Site 159
  • Forest Investigative Site 142
  • Forest Investigative Site 162
  • Forest Investigative Site 125
  • Forest Investigative Site 110
  • Forest Investigative Site 153
  • Forest Investigative Site 152
  • Forest Investigative Site 120
  • Forest Investigative Site 145
  • Forest Investigative Site 140
  • Forest Investigative Site 107
  • Forest Investigative Site 129
  • Forest Investigative Site 115
  • Forest Investigative Site 150
  • Forest Investigative Site 144
  • Forest Investigative Site 205
  • Forest Investigative Site 208
  • Forest Investigative Site 204
  • Forest Investigative Site 209
  • Forest Investigative Site 212
  • Forest Investigative Site 207
  • Forest Investigative Site 203
  • Forest Investigative Site 211
  • Forest Investigative Site 201
  • Forest Investigative Site 202
  • Forest Investigative Site 214
  • Forest Investigative Site 210
  • Forest Investigative Site 213
  • Forest Investigative Site 206
  • Forest Investigative Site 501
  • Forest Investigative Site 503
  • Forest Investigative Site 314
  • Forest Investigative Site 312
  • Forest Investigative Site 309
  • Forest Investigative Site 307
  • Forest Investigative Site 308
  • Forest Investigatie Site 301
  • Forest Investigative Site 306
  • Forest Investigative Site 310
  • Forest Investigative Site 302
  • Forest Investigative Site 304
  • Forest Investigative Site 315
  • Forest Investigative Site 311
  • Forest Investigative Site 303
  • Forest Investigative Site 313
  • Forest Investigative Site 305
  • Forest Investigative Site 316
  • Forest Investigative Site 402
  • Forest Investigative Site 403
  • Forest Investigative Site 407
  • Forest Investigative Site 405
  • Forest Investigative Site 401
  • Forest Investigative Site 408
  • Forest Investigative Site 404
  • Forest Investigative Site 406
  • Forest Investigative Site 409

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Apadenoson

Adenosine

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Presence of myocardial perfusion defect based on SPECT-MPI

Secondary Outcome Measures

Incidence and subject rated intensity of most commonly reported side effects associated with use of adenosine compared to apadenoson in SPECT-MPI

Full Information

First Posted
March 4, 2011
Last Updated
April 27, 2012
Sponsor
Forest Laboratories
Collaborators
PPD
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1. Study Identification

Unique Protocol Identification Number
NCT01313572
Brief Title
Study of the Safety and Efficacy of Apadenoson for Detection of Myocardial Perfusion Defects Using SPECT MPI
Acronym
ASPECT2
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

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Terminated
Study Start Date
August 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories
Collaborators
PPD

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary Artery Disease, Myocardial Perfusion Imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
197 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Apadenoson
Arm Type
Experimental
Arm Description
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
Arm Title
Adenosine
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Apadenoson SPECT-MPI
Other Intervention Name(s)
BMS068645, DPC-A78445-00, DPH-068645-01, ATL146e, DWH 146e
Intervention Description
Apadenoson single bolus IV injection 100 or 150 ug
Intervention Type
Drug
Intervention Name(s)
Adenosine SPECT-MPI
Other Intervention Name(s)
Adenoscan
Intervention Description
Single IV infusion for 6 minutes at a rate of 140 µg/kg body weight per minute
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David B Bharucha, MD, PhD, FACC
Organizational Affiliation
Forest Laboratories
Official's Role
Study Director
Facility Information:
Facility Name
Forest Investigative Site 138
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Forest Investigative Site 146
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Forest Investigative Site 113
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72204
Country
United States
Facility Name
Forest Investigative Site 148
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Forest Investigative Site 154
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Forest Investigative Site 131
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Forest Investigative Site 156
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Forest Investigative Site 108
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Forest Investigative Site 111
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Forest Investigative Site 101
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Forest Investigative Site 163
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
Forest Investigative Site 135
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32141
Country
United States
Facility Name
Forest Investigative Site 102
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Facility Name
Forest Investigative Site 151
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Forest Investigative Site 105
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Forest Investigative Site 143
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Forest Investigative Site 137
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Forest Investigative Site 103
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Forest Investigative Site 123
City
Naples
State/Province
Florida
ZIP/Postal Code
34119
Country
United States
Facility Name
Forest Investigative Site 161
City
Safety Harbor
State/Province
Florida
ZIP/Postal Code
34695
Country
United States
Facility Name
Forest Investigative Site 118
City
Cumming
State/Province
Georgia
ZIP/Postal Code
30041
Country
United States
Facility Name
Forest Investigative Site 119
City
Tucker
State/Province
Georgia
ZIP/Postal Code
30084
Country
United States
Facility Name
Forest Investigative Site 166
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Forest Investigative Site 109
City
Hammond
State/Province
Louisiana
ZIP/Postal Code
70403
Country
United States
Facility Name
Forest Investigative Site 122
City
Slidell
State/Province
Louisiana
ZIP/Postal Code
70458
Country
United States
Facility Name
Forest Investigative Site 121
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
Facility Name
Forest Investigative Site 124
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Forest Investigative Site 149
City
Hollywood
State/Province
Maryland
ZIP/Postal Code
20636
Country
United States
Facility Name
Forest Investigative Site 104
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Forest Investigative Site 134
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Forest Investigative Site 159
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Forest Investigative Site 142
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Forest Investigative Site 162
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Forest Investigative Site 125
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
Forest Investigative Site 110
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Forest Investigative Site 153
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
Forest Investigative Site 152
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Forest Investigative Site 120
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Forest Investigative Site 145
City
Johnson City,
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
Facility Name
Forest Investigative Site 140
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Forest Investigative Site 107
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Forest Investigative Site 129
City
Houston
State/Province
Texas
ZIP/Postal Code
77070
Country
United States
Facility Name
Forest Investigative Site 115
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Facility Name
Forest Investigative Site 150
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Forest Investigative Site 144
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
Facility Name
Forest Investigative Site 205
City
Ciudad Autónoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1122AAL
Country
Argentina
Facility Name
Forest Investigative Site 208
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000DIF
Country
Argentina
Facility Name
Forest Investigative Site 204
City
Rosario
State/Province
Santa Fé
ZIP/Postal Code
S2000ODA
Country
Argentina
Facility Name
Forest Investigative Site 209
City
Buenos Aires
ZIP/Postal Code
1177AEJ
Country
Argentina
Facility Name
Forest Investigative Site 212
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
1201
Country
Argentina
Facility Name
Forest Investigative Site 207
City
Cordoba
ZIP/Postal Code
X5000JJS
Country
Argentina
Facility Name
Forest Investigative Site 203
City
Cordoba
ZIP/Postal Code
X5003FGG
Country
Argentina
Facility Name
Forest Investigative Site 211
City
Córdoba
ZIP/Postal Code
X5000AAX
Country
Argentina
Facility Name
Forest Investigative Site 201
City
Godoy Cruz,
ZIP/Postal Code
M5501AAJ
Country
Argentina
Facility Name
Forest Investigative Site 202
City
Godoy Cruz
ZIP/Postal Code
M5501AAJ
Country
Argentina
Facility Name
Forest Investigative Site 214
City
La Plata
ZIP/Postal Code
B1925XAC
Country
Argentina
Facility Name
Forest Investigative Site 210
City
Mar del Plata
ZIP/Postal Code
B7600FZD
Country
Argentina
Facility Name
Forest Investigative Site 213
City
San Isidro
ZIP/Postal Code
B1642CAD
Country
Argentina
Facility Name
Forest Investigative Site 206
City
Santa fe
ZIP/Postal Code
S3000AOL
Country
Argentina
Facility Name
Forest Investigative Site 501
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
Forest Investigative Site 503
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Forest Investigative Site 314
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80010-030
Country
Brazil
Facility Name
Forest Investigative Site 312
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
80320-320
Country
Brazil
Facility Name
Forest Investigative Site 309
City
São José do Rio Preto
State/Province
São Paulo
ZIP/Postal Code
15015-210
Country
Brazil
Facility Name
Forest Investigative Site 307
City
Belo Horizonte
ZIP/Postal Code
30130-100
Country
Brazil
Facility Name
Forest Investigative Site 308
City
Belo Horizonte
ZIP/Postal Code
30140-000
Country
Brazil
Facility Name
Forest Investigatie Site 301
City
Curitiba
ZIP/Postal Code
80050-010
Country
Brazil
Facility Name
Forest Investigative Site 306
City
Goiânia
ZIP/Postal Code
74823-470
Country
Brazil
Facility Name
Forest Investigative Site 310
City
Maceió
ZIP/Postal Code
57021-500
Country
Brazil
Facility Name
Forest Investigative Site 302
City
Porto Alegre
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Forest Investigative Site 304
City
Recife
ZIP/Postal Code
52010-010
Country
Brazil
Facility Name
Forest Investigative Site 315
City
Rio de Janeiro
ZIP/Postal Code
22251-050
Country
Brazil
Facility Name
Forest Investigative Site 311
City
Rio de Janeiro
ZIP/Postal Code
22640-102
Country
Brazil
Facility Name
Forest Investigative Site 303
City
Salvador
ZIP/Postal Code
40050-410
Country
Brazil
Facility Name
Forest Investigative Site 313
City
Sao Paulo
ZIP/Postal Code
04012-180
Country
Brazil
Facility Name
Forest Investigative Site 305
City
São José do Rio Preto
ZIP/Postal Code
15015-205
Country
Brazil
Facility Name
Forest Investigative Site 316
City
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
Forest Investigative Site 402
City
Gouda
State/Province
Bleuland
ZIP/Postal Code
2803 HH
Country
Netherlands
Facility Name
Forest Investigative Site 403
City
Apeldoorn
State/Province
Lukas
ZIP/Postal Code
7334 DZ
Country
Netherlands
Facility Name
Forest Investigative Site 407
City
Amsterdam
ZIP/Postal Code
1061 AE
Country
Netherlands
Facility Name
Forest Investigative Site 405
City
Delft
ZIP/Postal Code
2625 AD
Country
Netherlands
Facility Name
Forest Investigative Site 401
City
Doetinchem
ZIP/Postal Code
7009 BL
Country
Netherlands
Facility Name
Forest Investigative Site 408
City
Hengelo
ZIP/Postal Code
7555 DL
Country
Netherlands
Facility Name
Forest Investigative Site 404
City
Hoogeveen
ZIP/Postal Code
7909 AA
Country
Netherlands
Facility Name
Forest Investigative Site 406
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Forest Investigative Site 409
City
Rotterdam
ZIP/Postal Code
3045 PM
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

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

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