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

Coronary Artery Disease Clinical Trial

— ASPECT  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00990327
• Other study ID #: PGX-III-AP-001
• Status: Terminated
• Phase: Phase 3
• First received: October 2, 2009
• Last updated: April 27, 2012
• Start date: November 2009
• 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 AdministrationBrazil: Ministry of Health
• 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 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 863
• 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:

• 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

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
Brazil	Forest Investigative Site 308	Belo Horizonte - MG
Brazil	Forest Investigative Site 317	Brasília - DF
Brazil	Forest Investigative Site 311	Campinas
Brazil	Forest Investigative Site 305	Curitiba
Brazil	Forest Investigative Site 307	Curitiba	Parana
Brazil	Forest Investigative Site 313	Curitiba
Brazil	Forest Investigative Site 314	Curitiba - PR
Brazil	Forest Investigative Site 316	Niteroi
Brazil	Forest Investigative Site 309	Passo Fundo - RS
Brazil	Forest Investigative Site 310	Porto Alegre - RS
Brazil	Forest Investigative Site 318	Porto Alegre - RS
Brazil	Forest Investigative Site 315	Rio de Janeiro
Brazil	Forest Investigative Site 304	Rio de Janeiro - RJ
Brazil	Forest Investigative Site 319	Rio de Janeiro - RJ
Brazil	Forest Investigative Site 306	Salvador	Bahia
Brazil	Forest Investigative Site 301	Salvador - BA
Brazil	Forest Investigative Site 303	São José
Brazil	Forest Investigative Site 302	São Paulo - SP
Brazil	Forest Investigative Site 312	São Paulo - SP
United States	Forest Investigative Site 235	Akron	Ohio
United States	Forest Investigative Site 115	Albany	New York
United States	Forest Investigative Site 202	Alexandria	Louisiana
United States	Forest Investigative Site 128	Amarillo	Texas
United States	Forest Investigative Site 114	Auburn	Maine
United States	Forest Investigative Site 155	Augusta	Georgia
United States	Forest Investigative Site 193	Baltimore	Maryland
United States	Forest Investigative Site 190	Bend	Oregon
United States	Forest Investigative Site 152	Birmingham	Alabama
United States	Forest Investigative Site 137	Boise	Idaho
United States	Forest Investigative Site 138	Boise	Idaho
United States	Forest Investigative Site 212	Buffalo	New York
United States	Forest Investigative Site 213	Camp Hill	Pennsylvania
United States	Forest Investigative Site 149	Charleston	South Carolina
United States	Forest Investigative Site 210	Charlottesville	Virginia
United States	Forest Investigative Site 227	Chicago	Illinois
United States	Forest Investigative Site 161	Columbus	Ohio
United States	Forest Investigative Site163	Columbus	Ohio
United States	Forest Investigative Site 257	Covington	Louisiana
United States	Forest Investigative Site 248	Crestview Hills	Kentucky
United States	Forest Investigative Site 199	Cumming	Georgia
United States	Forest Investigative Site 205	Daytona Beach	Florida
United States	Forest Investigative Site 143	Detroit	Michigan
United States	Forest Investigative Site 233	Edgewater	Florida
United States	Forest Investigative Site 214	Fargo	North Dakota
United States	Forest Investigative Site 164	Gainesville	Florida
United States	Forest Investigative Site 252	Grapevine	Texas
United States	Forest Investigative Site 132	Hartford	Connecticut
United States	Forest Investigative Site 116	Honolulu	Hawaii
United States	Forest Investigative Site 113	Indianapolis	Indiana
United States	Forest Investigative Site 118	Jacksonville	Florida
United States	Forest Investigative Site 120	Jacksonville	Florida
United States	Forest Investigative Site 124	Jacksonville	Florida
United States	Forest Investigative Site 125	Jacksonville	Florida
United States	Forest Investigative Site 198	Jacksonville	Florida
United States	Forest Investigative Site 126	Jacksonville Beach	Florida
United States	Forest Investigative Site 167	Johnson City	Tennessee
United States	Forest Investigative Site 192	Johnson City	Tennessee
United States	Forest Investigative Site 228	Joliet	Illinois
United States	Forest Investigative Site 230	Jonesboro	Arkansas
United States	Forest Investigative Site 176	Kansas City	Missouri
United States	Forest Investigative Site 165	Kingston	New York
United States	Forest Investigative Site 108	La Mesa	California
United States	Forest Investigative Site 153	Little Rock	Arkansas
United States	Forest Investigative Site 156	Lorain	Ohio
United States	Forest Investigative Site 144	Madison	Wisconsin
United States	Forest Investigative Site 224	Manhasset	New York
United States	Forest Investigative Site 139	Massapequa	New York
United States	Forest Investigative Site 200	McKinney	Texas
United States	Forest Investigative Site 180	Melbourne	Florida
United States	Forest Investigative Site 106	Miami	Florida
United States	Forest Investigative Site 183	Miami	Florida
United States	Forest Investigative Site 111	Mission Viejo	California
United States	Forest Investigative Site 188	Missoula	Montana
United States	Forest Investigative Site 250	Mobile	Alabama
United States	Forest Investigative Site 234	Murrieta	California
United States	Forest Investigative Site 201	Naples	Florida
United States	Forest Investigative Site 102	Newark	Delaware
United States	Forest Investigative Site 182	Oklahoma City	Oklahoma
United States	Forest Investigative Site 133	Overland Park	Kansas
United States	Forest Investigative Site 241	Owensboro	Kentucky
United States	Forest Investigative Site 207	Petoskey	Michigan
United States	Forest Investigative Site 134	Philadelphia	Pennsylvania
United States	Forest Investigative Site 154	Philadelphia	Pennsylvania
United States	Forest Investigative Site 218	Philadelphia	Pennsylvania
United States	Forest Investigative Site 191	Phoenix	Arizona
United States	Forest Investigative Site 223	Phoenix	Arizona
United States	Forest Investigative Site 160	Pittsburgh	Pennsylvania
United States	Forest Investigative Site 181	Plano	Texas
United States	Forest Investigative Site 217	Portland	Oregon
United States	Forest Investigative Site 236	Provo	Utah
United States	Forest Investigative Site 208	Raleigh	North Carolina
United States	Forest Investigative Site 110	Roanoke	Virginia
United States	Forest Investigative Site 146	Roseville	California
United States	Forest Investigative Site 122	Sacramento	California
United States	Forest Investigative Site 225	Sacramento	California
United States	Forest Investigative Site 177	Saint Louis Park	Minnesota
United States	Forest Investigative Site 253	San Antonio	Texas
United States	Forest Investigative Site 185	Sandusky	Ohio
United States	Forest Investigative Site 249	Sanford	North Carolina
United States	Forest Investigative Site 105	Santa Rosa	California
United States	Forest Investigative Site 107	Scarborough	Maine
United States	Forest Investigative Site 151	Seattle	Washington
United States	Forest Investigative Site 187	Sellersville	Pennsylvania
United States	Forest Investigative Site 172	Simpsonville	South Carolina
United States	Forest Investigative Site 109	South Portland	Maine
United States	Forest Investigative Site 229	Spartanburg	South Carolina
United States	Forest Investigative Site 142	Spokane	Washington
United States	Forest Investigative Site 159	St. Louis	Missouri
United States	Forest Investigative Site 186	Sugar Land	Texas
United States	Forest Investigative Site 240	Tampa	Florida
United States	Forest Investigative Site 231	Tomball	Texas
United States	Forest Investigative Site 232	Tomball	Texas
United States	Forest Investigative Site 204	Tucker	Georgia
United States	Forest Investigative Site 131	Tupelo	Mississippi
United States	Forest Investigative Site 168	Valparaiso	Indiana
United States	Forest Investigative Site 196	Walnut Creek	California
United States	Forest Investigative Site 238	Wellington	Florida
United States	Forest Investigative Site 171	West Des Moines	Iowa
United States	Forest Investigative Site 101	Westlake	Ohio
United States	Forest investigative Site 197	Westminster	Maryland
United States	Forest Investigative Site 173	Winfield	Illinois
United States	Forest Investigative Site 117	Wyomissing	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Forest Laboratories	PPD

Countries where clinical trial is conducted

United States,  Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of myocardial perfusion defect as based on SPECT-MPI		Up to 2 hours after study drug administration in Period 1 and 2	Yes
Secondary	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		1 hour after Period 2 study drug administration	No