Study of the Safety and Efficacy of Apadenoson for Detection of Myocardial Perfusion Defects Using SPECT MPI (ASPECT2)
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease |
Drug: Apadenoson SPECT-MPI Drug: Adenosine SPECT-MPI |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, 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) |
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 197 |
| Study Start Date: | August 2011 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
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:
Drug: Adenosine SPECT-MPI
Single IV infusion for 6 minutes at a rate of 140 µg/kg body weight per minute
Other Name: Adenoscan
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Show 86 Study Locations| Study Director: | David B Bharucha, MD, PhD, FACC | Forest Laboratories |
More Information
No publications provided
| Responsible Party: | Forest Laboratories |
| ClinicalTrials.gov Identifier: | NCT01313572 History of Changes |
| Other Study ID Numbers: | PGX-III-AP-002 |
| Study First Received: | March 4, 2011 |
| Last Updated: | April 27, 2012 |
| Health Authority: | United States: Food and Drug Administration |
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 Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anti-Arrhythmia Agents Cardiovascular Agents Vasodilator Agents |
ClinicalTrials.gov processed this record on May 16, 2013