ADVANCE MPI 2: Study of Regadenoson Versus Adenoscan┬« in Patients Undergoing Myocardial Perfusion Imaging (MPI)
Information source: Gilead Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Artery Disease
Intervention: Regadenoson (Drug); Adenosine (Drug)
Phase: Phase 3
Sponsored by: Gilead Sciences
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.
Official title: A Phase III, Randomized, Double-Blind Study of Intravenous CVT-3146 Versus Adenoscan« in Patients Undergoing Stress Myocardial Perfusion Imaging
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
Primary outcome: Non-inferiority of regadenoson to Adenoscan for use in SPECT myocardial perfusion imaging in assessing reversible perfusion defects
Safety and tolerability comparison of regadenoson to Adenoscan
Additional comparisons of images obtained with regadenoson to those obtained with Adenoscan
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.
Minimum age: 18 Years.
Maximum age: N/A.
- Referred for a clinically indicated pharmacological stress SPECT myocardial perfusion
- 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
Locations and Contacts
Multiple study locations (see Central Contact); CV Therapeutics, Inc., Palo Alto, California 94304, United States
Starting date: April 2004
Last updated: November 24, 2009