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

Stopped early · Phase 3

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT01313572

Run by

Forest Laboratories

People needed

197

Starts

2011-08-01

Expected to finish

2012-04-01

Last updated by the study team

2012-05-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Forest Investigative Site 146 — Phoenix, Arizona, United States
• Forest Investigative Site 113 — Little Rock, Arkansas, United States
• Forest Investigative Site 148 — Beverly Hills, California, United States
• Forest Investigative Site 154 — Los Angeles, California, United States
• Forest Investigative Site 131 — Mission Viejo, California, United States
• Forest Investigative Site 156 — Denver, Colorado, United States
• Forest Investigative Site 108 — New Haven, Connecticut, United States
• Forest Investigative Site 111 — Newark, Delaware, United States
• Forest Investigative Site 101 — Clearwater, Florida, United States
• Forest Investigative Site 163 — Daytona Beach, Florida, United States
• Forest Investigative Site 135 — Edgewater, Florida, United States
• Forest Investigative Site 102 — Inverness, Florida, United States
• Forest Investigative Site 151 — Jacksonville, Florida, United States
• Forest Investigative Site 105 — Melbourne, Florida, United States
• Forest Investigative Site 143 — Melbourne, Florida, United States
• Forest Investigative Site 137 — Miami, Florida, United States
• Forest Investigative Site 103 — Miami, Florida, United States
• Forest Investigative Site 123 — Naples, Florida, United States
• Forest Investigative Site 161 — Safety Harbor, Florida, United States
• Forest Investigative Site 118 — Cumming, Georgia, United States
• Forest Investigative Site 119 — Tucker, Georgia, United States
• Forest Investigative Site 166 — Covington, Louisiana, United States
• Forest Investigative Site 109 — Hammond, Louisiana, United States
• Forest Investigative Site 122 — Slidell, Louisiana, United States
• Forest Investigative Site 138 — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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