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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Enrollment
787
0.4 mg, bolus intravenous injection
0.14 mg/kg/min for 6 minutes, intravenous infusion
Multiple study locations (see Central Contact); CV Therapeutics, Inc.
Palo Alto, California, United States
Non-inferiority of regadenoson to Adenoscan for use in SPECT myocardial perfusion imaging in assessing reversible perfusion defects
Time frame: After radiopharmaceutical administration
Safety and tolerability comparison of regadenoson to Adenoscan
Time frame: Up to two weeks
Additional comparisons of images obtained with regadenoson to those obtained with Adenoscan
Time frame: After radiopharmaceutical administration
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