Study of the Safety and Efficacy of Apadenoson for Detection of Myocardial Perfusion Defects Using SPECT MPI (ASPECT)
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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: NCT00990327 |
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Recruitment Status
:
Terminated
First Posted
: October 6, 2009
Last Update Posted
: May 1, 2012
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Sponsor:
Forest Laboratories
Collaborator:
PPD
Information provided by (Responsible Party):
Forest Laboratories
- Study Details
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- No Results Posted
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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 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 |
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 (Clinical Trial) |
| Actual Enrollment : | 863 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Diagnostic |
| Official 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) |
| Study Start Date : | November 2009 |
| Actual Primary Completion Date : | April 2012 |
| Actual Study Completion Date : | April 2012 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Coronary Artery Disease
Drug Information available for:
Adenosine
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: Apadenoson SPECT-MPI
Apadenoson single bolus IV injection 100 or 150 ug
Other Name: 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
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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.
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Drug: Apadenoson SPECT-MPI
Apadenoson single bolus IV injection 100 or 150 ug
Other Name: 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
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Primary Outcome Measures
:
- 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 ]
Secondary Outcome Measures
:
- 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 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
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): NCT00990327
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Locations
| United States, Alabama | |
| Forest Investigative Site 152 | |
| Birmingham, Alabama, United States, 35294 | |
| Forest Investigative Site 250 | |
| Mobile, Alabama, United States, 36608 | |
| United States, Arizona | |
| Forest Investigative Site 223 | |
| Phoenix, Arizona, United States, 85006 | |
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| Phoenix, Arizona, United States, 85020 | |
| United States, Arkansas | |
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| Jonesboro, Arkansas, United States, 72401 | |
| Forest Investigative Site 153 | |
| Little Rock, Arkansas, United States, 72204 | |
| United States, California | |
| Forest Investigative Site 108 | |
| La Mesa, California, United States, 91942 | |
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| Mission Viejo, California, United States, 92691 | |
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| Murrieta, California, United States, 92562 | |
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| Roseville, California, United States, 95661 | |
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| Sacramento, California, United States, 95816 | |
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| Jacksonville Beach, Florida, United States, 32250 | |
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| Jacksonville, Florida, United States, 32207 | |
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| Jacksonville, Florida, United States, 32216 | |
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| Jacksonville, Florida, United States, 32216 | |
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| Jacksonville, Florida, United States, 32258 | |
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| Miami, Florida, United States, 33136 | |
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| United States, Illinois | |
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| Chicago, Illinois, United States, 60612 | |
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| Indianapolis, Indiana, United States, 46260 | |
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| Forest Investigative Site 144 | |
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| Forest Investigative Site 306 | |
| Salvador, Bahia, Brazil, 41148-900 | |
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| Curitiba, Parana, Brazil, 80010-030 | |
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| Belo Horizonte - MG, Brazil, 30150-221 | |
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| Curitiba, Brazil, 80050-010 | |
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| Curitiba, Brazil, 83430-000 | |
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| Salvador - BA, Brazil, 41810-010 | |
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| São José, Brazil, 88103-460 | |
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| São Paulo - SP, Brazil, 04012-180 | |
| Forest Investigative Site 312 | |
| São Paulo - SP, Brazil, 05403-000 | |
Sponsors and Collaborators
Forest Laboratories
PPD
Investigators
| Study Director: | David B Bharucha, MD, PhD, FACC | Forest Laboratories |
| Responsible Party: | Forest Laboratories |
| ClinicalTrials.gov Identifier: | NCT00990327 History of Changes |
| Other Study ID Numbers: |
PGX-III-AP-001 |
| First Posted: | October 6, 2009 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:
|
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 |