Back to resultsADVANCE MPI 1: Study of Regadenoson Versus Adenoscan® in Patients Undergoing Myocardial Perfusion Imaging (MPI)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Regadenoson
Adenosine
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Lexiscan, Regadenoson, Adenoscan®, Adenosine, SPECT Myocardial Perfusion Imaging, Reversible Perfusion Defect
Eligibility 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
Sites / Locations
- Multiple study locations (see Central Contact); CV Therapeutics, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Regadenoson
Adenoscan
Outcomes
Primary Outcome Measures
Non-inferiority of regadenoson to Adenoscan for use in single photon emission computed tomography (SPECT) myocardial perfusion imaging in assessing reversible perfusion defects
Secondary Outcome Measures
Safety and tolerability comparison of regadenoson to Adenoscan
Additional comparisons of images obtained with regadenoson to those obtained with Adenoscan
Full Information
NCT ID
NCT00208299
First Posted
September 13, 2005
Last Updated
November 24, 2009
Sponsor
Gilead Sciences
Collaborators
Astellas Pharma US, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00208299
Brief Title
ADVANCE MPI 1: Study of Regadenoson Versus Adenoscan® in Patients Undergoing Myocardial Perfusion Imaging (MPI)
Official Title
A Phase III, Randomized, Double-Blind Study of Intravenous CVT-3146 Versus Adenoscan® in Patients Undergoing Stress Myocardial Perfusion Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Gilead Sciences
Collaborators
Astellas Pharma US, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 1 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:
to compare the pharmacological stress SPECT images obtained with regadenoson to those obtained with Adenoscan, and
to compare the safety and tolerability of the two stress agents.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Lexiscan, Regadenoson, Adenoscan®, Adenosine, SPECT Myocardial Perfusion Imaging, Reversible Perfusion Defect
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1231 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Regadenoson
Arm Title
2
Arm Type
Active Comparator
Arm Description
Adenoscan
Intervention Type
Drug
Intervention Name(s)
Regadenoson
Other Intervention Name(s)
Lexiscan, CVT-3146
Intervention Description
0.4 mg, bolus intravenous injection
Intervention Type
Drug
Intervention Name(s)
Adenosine
Other Intervention Name(s)
Adenoscan
Intervention Description
0.14 mg/kg/min for 6 minutes, intravenous infusion
Primary Outcome Measure Information:
Title
Non-inferiority of regadenoson to Adenoscan for use in single photon emission computed tomography (SPECT) myocardial perfusion imaging in assessing reversible perfusion defects
Time Frame
After radiopharmaceutical administration
Secondary Outcome Measure Information:
Title
Safety and tolerability comparison of regadenoson to Adenoscan
Time Frame
Up to two weeks
Title
Additional comparisons of images obtained with regadenoson to those obtained with Adenoscan
Time Frame
After radiopharmaceutical administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Multiple study locations (see Central Contact); CV Therapeutics, Inc.
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.adenoscan.com
Description
Adenoscan®
Learn more about this trial
ADVANCE MPI 1: Study of Regadenoson Versus Adenoscan® in Patients Undergoing Myocardial Perfusion Imaging (MPI)
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