ADVANCE MPI 2: Study of Regadenoson Versus Adenoscan® in Patients Undergoing Myocardial Perfusion Imaging (MPI)
Information source: CV Therapeutics
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Artery Disease
Intervention: Regadenoson (Drug); Adenosine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: CV Therapeutics
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.
Clinical Details
Official title: A Phase III, Randomized, Double-Blind Study of Intravenous CVT-3146 Versus Adenoscan® in Patients Undergoing Stress Myocardial Perfusion Imaging
Study design: Diagnostic, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Non-inferiority of regadenoson to Adenoscan for use in SPECT myocardial perfusion imaging in assessing reversible perfusion defects
Secondary outcome: Safety and tolerability comparison of regadenoson to AdenoscanAdditional comparisons of images obtained with regadenoson to those obtained with Adenoscan
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Multiple study locations (see Central Contact); CV Therapeutics, Inc., Palo Alto, California 94304, United States
Additional Information
CV Therapeutics, Inc. Adenoscan®
Starting date: April 2004
Ending date: June 2005
Last updated: April 7, 2008
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