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Study of the Safety and Effic...

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

Last Updated: 2012-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

863 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2012-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Apadenoson SPECT-MPI

Intervention Type DRUG

Apadenoson single bolus IV injection 100 or 150 ug

Adenosine SPECT-MPI

Intervention Type DRUG

Single IV infusion for 6 minutes at a rate of 140 µg/kg body weight per minute.

Adenosine

Group Type ACTIVE_COMPARATOR

Apadenoson SPECT-MPI

Intervention Type DRUG

Apadenoson single bolus IV injection 100 or 150 ug

Adenosine SPECT-MPI

Intervention Type DRUG

Single IV infusion for 6 minutes at a rate of 140 µg/kg body weight per minute.

Interventions

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Apadenoson SPECT-MPI

Apadenoson single bolus IV injection 100 or 150 ug

Intervention Type DRUG

Adenosine SPECT-MPI

Single IV infusion for 6 minutes at a rate of 140 µg/kg body weight per minute.

Intervention Type DRUG

Other Intervention Names

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DPC-A78445-00, DPH-068645-01, ATL146e, DWH 146e Adenoscan

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David B Bharucha, MD, PhD, FACC

Role: STUDY_DIRECTOR

Forest Laboratories

Locations

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Forest Investigative Site 152

Birmingham, Alabama, United States

Site Status

Forest Investigative Site 250

Mobile, Alabama, United States

Site Status

Forest Investigative Site 223

Phoenix, Arizona, United States

Site Status

Forest Investigative Site 191

Phoenix, Arizona, United States

Site Status

Forest Investigative Site 230

Jonesboro, Arkansas, United States

Site Status

Forest Investigative Site 153

Little Rock, Arkansas, United States

Site Status

Forest Investigative Site 108

La Mesa, California, United States

Site Status

Forest Investigative Site 111

Mission Viejo, California, United States

Site Status

Forest Investigative Site 234

Murrieta, California, United States

Site Status

Forest Investigative Site 146

Roseville, California, United States

Site Status

Forest Investigative Site 225

Sacramento, California, United States

Site Status

Forest Investigative Site 122

Sacramento, California, United States

Site Status

Forest Investigative Site 105

Santa Rosa, California, United States

Site Status

Forest Investigative Site 196

Walnut Creek, California, United States

Site Status

Forest Investigative Site 132

Hartford, Connecticut, United States

Site Status

Forest Investigative Site 102

Newark, Delaware, United States

Site Status

Forest Investigative Site 205

Daytona Beach, Florida, United States

Site Status

Forest Investigative Site 233

Edgewater, Florida, United States

Site Status