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 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

NCT00990327

Run by

Forest Laboratories

People needed

863

Starts

2009-11-01

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…

• High pretest probability of CAD based on the ACC/AHA guidelines for relative risk, or past medical h/o CAD

You may not qualify if…

• 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

Where it is running

• Forest Investigative Site 250 — Mobile, Alabama, United States
• Forest Investigative Site 223 — Phoenix, Arizona, United States
• Forest Investigative Site 191 — Phoenix, Arizona, United States
• Forest Investigative Site 230 — Jonesboro, Arkansas, United States
• Forest Investigative Site 153 — Little Rock, Arkansas, United States
• Forest Investigative Site 108 — La Mesa, California, United States
• Forest Investigative Site 111 — Mission Viejo, California, United States
• Forest Investigative Site 234 — Murrieta, California, United States
• Forest Investigative Site 146 — Roseville, California, United States
• Forest Investigative Site 225 — Sacramento, California, United States
• Forest Investigative Site 122 — Sacramento, California, United States
• Forest Investigative Site 105 — Santa Rosa, California, United States
• Forest Investigative Site 196 — Walnut Creek, California, United States
• Forest Investigative Site 132 — Hartford, Connecticut, United States
• Forest Investigative Site 102 — Newark, Delaware, United States
• Forest Investigative Site 205 — Daytona Beach, Florida, United States
• Forest Investigative Site 233 — Edgewater, Florida, United States
• Forest Investigative Site 164 — Gainesville, Florida, United States
• Forest Investigative Site 120 — Jacksonville, Florida, United States
• Forest Investigative Site 198 — Jacksonville, Florida, United States
• Forest Investigative Site 118 — Jacksonville, Florida, United States
• Forest Investigative Site 124 — Jacksonville, Florida, United States
• Forest Investigative Site 125 — Jacksonville, Florida, United States
• Forest Investigative Site 126 — Jacksonville Beach, Florida, United States
• Forest Investigative Site 152 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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