Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01313572
Recruitment Status : Terminated
First Posted : March 11, 2011
Last Update Posted : May 1, 2012
Sponsor:
Collaborator:
PPD
Information provided by (Responsible Party):
Forest Laboratories

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Apadenoson SPECT-MPI Drug: Adenosine SPECT-MPI Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 197 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
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 Start Date : August 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Adenosine

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 Name: 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 Name: Adenoscan




Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01313572


  Hide Study Locations
Locations
Layout table for location information
United States, Arizona
Forest Investigative Site 138
Phoenix, Arizona, United States, 85006
Forest Investigative Site 146
Phoenix, Arizona, United States, 85020
United States, Arkansas
Forest Investigative Site 113
Little Rock, Arkansas, United States, 72204
United States, California
Forest Investigative Site 148
Beverly Hills, California, United States, 90210
Forest Investigative Site 154
Los Angeles, California, United States, 90048
Forest Investigative Site 131
Mission Viejo, California, United States, 92691
United States, Colorado
Forest Investigative Site 156
Denver, Colorado, United States, 80206
United States, Connecticut
Forest Investigative Site 108
New Haven, Connecticut, United States, 06510
United States, Delaware
Forest Investigative Site 111
Newark, Delaware, United States, 19713
United States, Florida
Forest Investigative Site 101
Clearwater, Florida, United States, 33756
Forest Investigative Site 163
Daytona Beach, Florida, United States, 32117
Forest Investigative Site 135
Edgewater, Florida, United States, 32141
Forest Investigative Site 102
Inverness, Florida, United States, 34452
Forest Investigative Site 151
Jacksonville, Florida, United States, 32209
Forest Investigative Site 105
Melbourne, Florida, United States, 32901
Forest Investigative Site 143
Melbourne, Florida, United States, 32901
Forest Investigative Site 137
Miami, Florida, United States, 33136
Forest Investigative Site 103
Miami, Florida, United States, 33173
Forest Investigative Site 123
Naples, Florida, United States, 34119
Forest Investigative Site 161
Safety Harbor, Florida, United States, 34695
United States, Georgia
Forest Investigative Site 118
Cumming, Georgia, United States, 30041
Forest Investigative Site 119
Tucker, Georgia, United States, 30084
United States, Louisiana
Forest Investigative Site 166
Covington, Louisiana, United States, 70433
Forest Investigative Site 109
Hammond, Louisiana, United States, 70403
Forest Investigative Site 122
Slidell, Louisiana, United States, 70458
United States, Maine
Forest Investigative Site 121
Auburn, Maine, United States, 04210
United States, Maryland
Forest Investigative Site 124
Annapolis, Maryland, United States, 21401
Forest Investigative Site 149
Hollywood, Maryland, United States, 20636
United States, Michigan
Forest Investigative Site 104
Detroit, Michigan, United States, 48201
Forest Investigative Site 134
Detroit, Michigan, United States, 48202
United States, Minnesota
Forest Investigative Site 159
Rochester, Minnesota, United States, 55905
United States, Missouri
Forest Investigative Site 142
Kansas City, Missouri, United States, 64114
United States, New Jersey
Forest Investigative Site 162
New Brunswick, New Jersey, United States, 08901
United States, New Mexico
Forest Investigative Site 125
Albuquerque, New Mexico, United States, 87108
United States, New York
Forest Investigative Site 110
New York, New York, United States, 10032
United States, Pennsylvania
Forest Investigative Site 153
Camp Hill, Pennsylvania, United States, 17011
Forest Investigative Site 152
Pittsburgh, Pennsylvania, United States, 15213
Forest Investigative Site 120
Wyomissing, Pennsylvania, United States, 19610
United States, Tennessee
Forest Investigative Site 145
Johnson City,, Tennessee, United States, 37604
Forest Investigative Site 140
Nashville, Tennessee, United States, 37203
United States, Texas
Forest Investigative Site 107
Houston, Texas, United States, 77024
Forest Investigative Site 129
Houston, Texas, United States, 77070
Forest Investigative Site 115
Plano, Texas, United States, 75024
Forest Investigative Site 150
Tomball, Texas, United States, 77375
United States, Utah
Forest Investigative Site 144
Provo, Utah, United States, 84604
Argentina
Forest Investigative Site 205
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1122AAL
Forest Investigative Site 208
Rosario, Santa Fe, Argentina, S2000DIF
Forest Investigative Site 204
Rosario, Santa Fé, Argentina, S2000ODA
Forest Investigative Site 209
Buenos Aires, Argentina, 1177AEJ
Forest Investigative Site 212
Ciudad Autonoma de Buenos Aires, Argentina, 1201
Forest Investigative Site 207
Cordoba, Argentina, X5000JJS
Forest Investigative Site 203
Cordoba, Argentina, X5003FGG
Forest Investigative Site 211
Córdoba, Argentina, X5000AAX
Forest Investigative Site 201
Godoy Cruz,, Argentina, M5501AAJ
Forest Investigative Site 202
Godoy Cruz, Argentina, M5501AAJ
Forest Investigative Site 214
La Plata, Argentina, B1925XAC
Forest Investigative Site 210
Mar del Plata, Argentina, B7600FZD
Forest Investigative Site 213
San Isidro, Argentina, B1642CAD
Forest Investigative Site 206
Santa fe, Argentina, S3000AOL
Belgium
Forest Investigative Site 501
Aalst, Belgium, 9300
Forest Investigative Site 503
Bruxelles, Belgium, 1200
Brazil
Forest Investigative Site 314
Curitiba, Parana, Brazil, 80010-030
Forest Investigative Site 312
Curitiba, Paraná, Brazil, 80320-320
Forest Investigative Site 309
São José do Rio Preto, São Paulo, Brazil, 15015-210
Forest Investigative Site 307
Belo Horizonte, Brazil, 30130-100
Forest Investigative Site 308
Belo Horizonte, Brazil, 30140-000
Forest Investigatie Site 301
Curitiba, Brazil, 80050-010
Forest Investigative Site 306
Goiânia, Brazil, 74823-470
Forest Investigative Site 310
Maceió, Brazil, 57021-500
Forest Investigative Site 302
Porto Alegre, Brazil, 90610-000
Forest Investigative Site 304
Recife, Brazil, 52010-010
Forest Investigative Site 315
Rio de Janeiro, Brazil, 22251-050
Forest Investigative Site 311
Rio de Janeiro, Brazil, 22640-102
Forest Investigative Site 303
Salvador, Brazil, 40050-410
Forest Investigative Site 313
Sao Paulo, Brazil, 04012-180
Forest Investigative Site 305
São José do Rio Preto, Brazil, 15015-205
Forest Investigative Site 316
São Paulo, Brazil, 05403-000
Netherlands
Forest Investigative Site 402
Gouda, Bleuland, Netherlands, 2803 HH
Forest Investigative Site 403
Apeldoorn, Lukas, Netherlands, 7334 DZ
Forest Investigative Site 407
Amsterdam, Netherlands, 1061 AE
Forest Investigative Site 405
Delft, Netherlands, 2625 AD
Forest Investigative Site 401
Doetinchem, Netherlands, 7009 BL
Forest Investigative Site 408
Hengelo, Netherlands, 7555 DL
Forest Investigative Site 404
Hoogeveen, Netherlands, 7909 AA
Forest Investigative Site 406
Maastricht, Netherlands, 6229 HX
Forest Investigative Site 409
Rotterdam, Netherlands, 3045 PM
Sponsors and Collaborators
Forest Laboratories
PPD
Investigators
Layout table for investigator information
Study Director: David B Bharucha, MD, PhD, FACC Forest Laboratories

Layout table for additonal information
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01313572     History of Changes
Other Study ID Numbers: PGX-III-AP-002
First Posted: March 11, 2011    Key Record Dates
Last Update Posted: May 1, 2012
Last Verified: April 2012
Keywords provided by Forest Laboratories:
Coronary Artery Disease
Myocardial Perfusion Imaging
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Adenosine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action