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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 (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.

Clinical Details

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)

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 based on SPECT-MPI

Secondary outcome: Incidence and subject rated intensity of most commonly reported side effects 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. 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

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

Criteria:

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

Locations and Contacts

Forest Investigative Site 209, Buenos Aires 1177AEJ, Argentina

Forest Investigative Site 212, Ciudad Autonoma de Buenos Aires 1201, Argentina

Forest Investigative Site 203, Cordoba X5003FGG, Argentina

Forest Investigative Site 207, Cordoba X5000JJS, Argentina

Forest Investigative Site 211, Córdoba X5000AAX, Argentina

Forest Investigative Site 201, Godoy Cruz, M5501AAJ, Argentina

Forest Investigative Site 202, Godoy Cruz M5501AAJ, Argentina

Forest Investigative Site 214, La Plata B1925XAC, Argentina

Forest Investigative Site 210, Mar del Plata B7600FZD, Argentina

Forest Investigative Site 213, San Isidro B1642CAD, Argentina

Forest Investigative Site 206, Santa fe S3000AOL, Argentina

Forest Investigative Site 501, Aalst 9300, Belgium

Forest Investigative Site 503, Bruxelles 1200, Belgium

Forest Investigative Site 307, Belo Horizonte 30130-100, Brazil

Forest Investigative Site 308, Belo Horizonte 30140-000, Brazil

Forest Investigatie Site 301, Curitiba 80050-010, Brazil

Forest Investigative Site 306, Goiânia 74823-470, Brazil

Forest Investigative Site 310, Maceió 57021-500, Brazil

Forest Investigative Site 302, Porto Alegre 90610-000, Brazil

Forest Investigative Site 304, Recife 52010-010, Brazil

Forest Investigative Site 311, Rio de Janeiro 22640-102, Brazil

Forest Investigative Site 315, Rio de Janeiro 22251-050, Brazil

Forest Investigative Site 303, Salvador 40050-410, Brazil

Forest Investigative Site 313, Sao Paulo 04012-180, Brazil

Forest Investigative Site 305, São José do Rio Preto 15015-205, Brazil

Forest Investigative Site 316, São Paulo 05403-000, Brazil

Forest Investigative Site 407, Amsterdam 1061 AE, Netherlands

Forest Investigative Site 405, Delft 2625 AD, Netherlands

Forest Investigative Site 401, Doetinchem 7009 BL, Netherlands

Forest Investigative Site 408, Hengelo 7555 DL, Netherlands

Forest Investigative Site 404, Hoogeveen 7909 AA, Netherlands

Forest Investigative Site 406, Maastricht 6229 HX, Netherlands

Forest Investigative Site 409, Rotterdam 3045 PM, Netherlands

Forest Investigative Site 138, Phoenix, Arizona 85006, United States

Forest Investigative Site 146, Phoenix, Arizona 85020, United States

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Forest Investigative Site 105, Melbourne, Florida 32901, United States

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Forest Investigative Site 104, Detroit, Michigan 48201, United States

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Forest Investigative Site 159, Rochester, Minnesota 55905, United States

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Forest Investigative Site 162, New Brunswick, New Jersey 08901, United States

Forest Investigative Site 125, Albuquerque, New Mexico 87108, United States

Forest Investigative Site 110, New York, New York 10032, United States

Forest Investigative Site 314, Curitiba, Parana 80010-030, Brazil

Forest Investigative Site 312, Curitiba, Paraná 80320-320, Brazil

Forest Investigative Site 153, Camp Hill, Pennsylvania 17011, United States

Forest Investigative Site 152, Pittsburgh, Pennsylvania 15213, United States

Forest Investigative Site 120, Wyomissing, Pennsylvania 19610, United States

Forest Investigative Site 208, Rosario, Santa Fe S2000DIF, Argentina

Forest Investigative Site 204, Rosario, Santa Fé S2000ODA, Argentina

Forest Investigative Site 309, São José do Rio Preto, São Paulo 15015-210, Brazil

Forest Investigative Site 145, Johnson City,, Tennessee 37604, United States

Forest Investigative Site 140, Nashville, Tennessee 37203, United States

Forest Investigative Site 107, Houston, Texas 77024, United States

Forest Investigative Site 129, Houston, Texas 77070, United States

Forest Investigative Site 115, Plano, Texas 75024, United States

Forest Investigative Site 150, Tomball, Texas 77375, United States

Forest Investigative Site 144, Provo, Utah 84604, United States

Additional Information

Starting date: August 2011
Last updated: April 27, 2012

Page last updated: August 20, 2015

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