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

Coronary Artery Disease Clinical Trial

— ASPECT2  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01313572
• Other study ID #: PGX-III-AP-002
• Status: Terminated
• Phase: Phase 3
• First received: March 4, 2011
• Last updated: April 27, 2012
• Start date: August 2011
• Est. completion date: April 2012

Study information

• Verified date: April 2012
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 197
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Apadenoson SPECT-MPI
Apadenoson single bolus IV injection 100 or 150 ug
• Adenosine SPECT-MPI
Single IV infusion for 6 minutes at a rate of 140 µg/kg body weight per minute

Locations

Country	Name	City	State
Argentina	Forest Investigative Site 209	Buenos Aires
Argentina	Forest Investigative Site 212	Ciudad Autonoma de Buenos Aires
Argentina	Forest Investigative Site 205	Ciudad Autónoma de Buenos Aires	Buenos Aires
Argentina	Forest Investigative Site 203	Cordoba
Argentina	Forest Investigative Site 207	Cordoba
Argentina	Forest Investigative Site 211	Córdoba
Argentina	Forest Investigative Site 202	Godoy Cruz
Argentina	Forest Investigative Site 201	Godoy Cruz,
Argentina	Forest Investigative Site 214	La Plata
Argentina	Forest Investigative Site 210	Mar del Plata
Argentina	Forest Investigative Site 204	Rosario	Santa Fé
Argentina	Forest Investigative Site 208	Rosario	Santa Fe
Argentina	Forest Investigative Site 213	San Isidro
Argentina	Forest Investigative Site 206	Santa fe
Belgium	Forest Investigative Site 501	Aalst
Belgium	Forest Investigative Site 503	Bruxelles
Brazil	Forest Investigative Site 307	Belo Horizonte
Brazil	Forest Investigative Site 308	Belo Horizonte
Brazil	Forest Investigatie Site 301	Curitiba
Brazil	Forest Investigative Site 312	Curitiba	Paraná
Brazil	Forest Investigative Site 314	Curitiba	Parana
Brazil	Forest Investigative Site 306	Goiânia
Brazil	Forest Investigative Site 310	Maceió
Brazil	Forest Investigative Site 302	Porto Alegre
Brazil	Forest Investigative Site 304	Recife
Brazil	Forest Investigative Site 311	Rio de Janeiro
Brazil	Forest Investigative Site 315	Rio de Janeiro
Brazil	Forest Investigative Site 303	Salvador
Brazil	Forest Investigative Site 305	São José do Rio Preto
Brazil	Forest Investigative Site 309	São José do Rio Preto	São Paulo
Brazil	Forest Investigative Site 313	Sao Paulo
Brazil	Forest Investigative Site 316	São Paulo
Netherlands	Forest Investigative Site 407	Amsterdam
Netherlands	Forest Investigative Site 403	Apeldoorn	Lukas
Netherlands	Forest Investigative Site 405	Delft
Netherlands	Forest Investigative Site 401	Doetinchem
Netherlands	Forest Investigative Site 402	Gouda	Bleuland
Netherlands	Forest Investigative Site 408	Hengelo
Netherlands	Forest Investigative Site 404	Hoogeveen
Netherlands	Forest Investigative Site 406	Maastricht
Netherlands	Forest Investigative Site 409	Rotterdam
United States	Forest Investigative Site 125	Albuquerque	New Mexico
United States	Forest Investigative Site 124	Annapolis	Maryland
United States	Forest Investigative Site 121	Auburn	Maine
United States	Forest Investigative Site 148	Beverly Hills	California
United States	Forest Investigative Site 153	Camp Hill	Pennsylvania
United States	Forest Investigative Site 101	Clearwater	Florida
United States	Forest Investigative Site 166	Covington	Louisiana
United States	Forest Investigative Site 118	Cumming	Georgia
United States	Forest Investigative Site 163	Daytona Beach	Florida
United States	Forest Investigative Site 156	Denver	Colorado
United States	Forest Investigative Site 104	Detroit	Michigan
United States	Forest Investigative Site 134	Detroit	Michigan
United States	Forest Investigative Site 135	Edgewater	Florida
United States	Forest Investigative Site 109	Hammond	Louisiana
United States	Forest Investigative Site 149	Hollywood	Maryland
United States	Forest Investigative Site 107	Houston	Texas
United States	Forest Investigative Site 129	Houston	Texas
United States	Forest Investigative Site 102	Inverness	Florida
United States	Forest Investigative Site 151	Jacksonville	Florida
United States	Forest Investigative Site 145	Johnson City,	Tennessee
United States	Forest Investigative Site 142	Kansas City	Missouri
United States	Forest Investigative Site 113	Little Rock	Arkansas
United States	Forest Investigative Site 154	Los Angeles	California
United States	Forest Investigative Site 105	Melbourne	Florida
United States	Forest Investigative Site 143	Melbourne	Florida
United States	Forest Investigative Site 103	Miami	Florida
United States	Forest Investigative Site 137	Miami	Florida
United States	Forest Investigative Site 131	Mission Viejo	California
United States	Forest Investigative Site 123	Naples	Florida
United States	Forest Investigative Site 140	Nashville	Tennessee
United States	Forest Investigative Site 162	New Brunswick	New Jersey
United States	Forest Investigative Site 108	New Haven	Connecticut
United States	Forest Investigative Site 110	New York	New York
United States	Forest Investigative Site 111	Newark	Delaware
United States	Forest Investigative Site 138	Phoenix	Arizona
United States	Forest Investigative Site 146	Phoenix	Arizona
United States	Forest Investigative Site 152	Pittsburgh	Pennsylvania
United States	Forest Investigative Site 115	Plano	Texas
United States	Forest Investigative Site 144	Provo	Utah
United States	Forest Investigative Site 159	Rochester	Minnesota
United States	Forest Investigative Site 161	Safety Harbor	Florida
United States	Forest Investigative Site 122	Slidell	Louisiana
United States	Forest Investigative Site 150	Tomball	Texas
United States	Forest Investigative Site 119	Tucker	Georgia
United States	Forest Investigative Site 120	Wyomissing	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Forest Laboratories	PPD

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Brazil,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of myocardial perfusion defect based on SPECT-MPI		Up to 2 hours after study drug administration in Period 1 and Period 2	No
Secondary	Incidence and subject rated intensity of most commonly reported side effects associated with use of adenosine compared to apadenoson in SPECT-MPI		Up to 2 hours after administration of study drug in Period 2	Yes