ADVANCE MPI 2: Study of Regadenoson Versus Adenoscan® in Patients Undergoing Myocardial Perfusion Imaging (MPI) - Tabular View

Tracking Information
First Received Date ^ICMJE	September 13, 2005
Last Updated Date	October 1, 2009
Start Date ^ICMJE	April 2004
Primary Completion Date	June 2005 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 7, 2008)	Non-inferiority of regadenoson to Adenoscan for use in SPECT myocardial perfusion imaging in assessing reversible perfusion defects [ Time Frame: After radiopharmaceutical administration ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: September 13, 2005)	Non-inferiority of regadenoson to Adenoscan for use in SPECT myocardial perfusion imaging in assessing reversible perfusion defects
Change History	Complete list of historical versions of study NCT00208312 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 7, 2008)	Safety and tolerability comparison of regadenoson to Adenoscan [ Time Frame: Up to two weeks ] [ Designated as safety issue: Yes ] Additional comparisons of images obtained with regadenoson to those obtained with Adenoscan [ Time Frame: After radiopharmaceutical administration ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: September 13, 2005)	Safety and tolerability comparison of regadenoson to Adenoscan Additional comparisons of images obtained with regadenoson to those obtained with Adenoscan

Descriptive Information
Brief Title ^ICMJE	ADVANCE MPI 2: Study of Regadenoson Versus Adenoscan® in Patients Undergoing Myocardial Perfusion Imaging (MPI)
Official Title ^ICMJE	A Phase III, Randomized, Double-Blind Study of Intravenous CVT-3146 Versus Adenoscan® in Patients Undergoing Stress Myocardial Perfusion Imaging
Brief Summary	Adenoscan® (adenosine) is an approved pharmacological stress agent indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately. The investigational drug, regadenoson (CVT-3146) is a selective A2A adenosine receptor agonist, the receptor responsible for coronary vasodilation, and is being studied for potential use as a pharmacologic stress agent in myocardial perfusion imaging (MPI) studies. This study will compare the safety and efficacy of regadenoson to that of Adenoscan in detecting reversible myocardial perfusion defects.
Detailed Description	ADVANCE MPI 2 is a multi-national, double-blind, randomized, active-controlled, parallel group clinical trial to evaluate the safety and efficacy of regadenoson in SPECT MPI compared to that of the approved pharmacological stress agent, Adenoscan. Patients referred for a clinically indicated pharmacological stress MPI study will be eligible for enrollment. The trial is designed: (1) to compare the pharmacological stress SPECT images obtained with regadenoson to those obtained with Adenoscan, and (2) to compare the safety and tolerability of the two stress agents.
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Diagnostic, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Coronary Artery Disease
Intervention ^ICMJE	Drug: Regadenoson Drug: Adenosine
Study Arms / Comparison Groups	Experimental: Regadenoson Active Comparator: Adenoscan
Publications *	Iskandrian AE, Bateman TM, Belardinelli L, Blackburn B, Cerqueira MD, Hendel RC, Lieu H, Mahmarian JJ, Olmsted A, Underwood SR, Vitola J, Wang W; ADVANCE MPI Investigators. Adenosine versus regadenoson comparative evaluation in myocardial perfusion imaging: results of the ADVANCE phase 3 multicenter international trial. J Nucl Cardiol. 2007 Sep-Oct;14(5):645-58.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	787
Completion Date	June 2005
Primary Completion Date	June 2005 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Referred for a clinically indicated pharmacological stress SPECT myocardial perfusion imaging study Exclusion Criteria: Any condition precluding the safe administration of Adenoscan for a SPECT myocardial perfusion imaging study Pregnant or breast-feeding, or (if pre-menopausal), not practicing acceptable method of birth control
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00208312
Responsible Party	Philip Sager, Vice President, Clinical Research, Gilead Sciences
Study ID Numbers ^ICMJE	CVT 5132
Study Sponsor ^ICMJE	CV Therapeutics
Collaborators ^ICMJE	Astellas Pharma US, Inc.
Investigators ^ICMJE
Information Provided By	CV Therapeutics
Verification Date	October 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP