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

Information source: Forest Laboratories
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Coronary Artery Disease

Intervention: Apadenoson SPECT-MPI (Drug); Adenosine SPECT-MPI (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Forest Laboratories

Official(s) and/or principal investigator(s):
David B Bharucha, MD, PhD, FACC, Study Director, Affiliation: Forest Laboratories

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Primary outcome: Presence of myocardial perfusion defect as based on SPECT-MPI

Secondary outcome: 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

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. 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Forest Investigative Site 308, Belo Horizonte - MG 30150-221, Brazil

Forest Investigative Site 317, Brasília - DF 70390-700, Brazil

Forest Investigative Site 311, Campinas 13060-803, Brazil

Forest Investigative Site 314, Curitiba - PR 80320-320, Brazil

Forest Investigative Site 305, Curitiba 83430-000, Brazil

Forest Investigative Site 313, Curitiba 80050-010, Brazil

Forest Investigative Site 316, Niteroi 24020-350, Brazil

Forest Investigative Site 309, Passo Fundo - RS 99010-080, Brazil

Forest Investigative Site 310, Porto Alegre - RS 90035-903, Brazil

Forest Investigative Site 318, Porto Alegre - RS 90020-090, Brazil

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Forest Investigative Site 301, Salvador - BA 41810-010, Brazil

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Additional Information

Starting date: November 2009
Last updated: April 27, 2012

Page last updated: August 20, 2015

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