ADVANCE MPI 2: Study of Regadenoson Versus Adenoscan® in Patients Undergoing Myocardial Perfusion Imaging (MPI)
- Registration Number
- NCT00208312
- Lead Sponsor
- Gilead Sciences
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 787
- Referred for a clinically indicated pharmacological stress SPECT myocardial perfusion imaging study
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Regadenoson Regadenoson 2 Adenosine Adenoscan
- Primary Outcome Measures
Name Time Method Non-inferiority of regadenoson to Adenoscan for use in SPECT myocardial perfusion imaging in assessing reversible perfusion defects After radiopharmaceutical administration
- Secondary Outcome Measures
Name Time Method Safety and tolerability comparison of regadenoson to Adenoscan Up to two weeks Additional comparisons of images obtained with regadenoson to those obtained with Adenoscan After radiopharmaceutical administration
Trial Locations
- Locations (1)
Multiple study locations (see Central Contact); CV Therapeutics, Inc.
🇺🇸Palo Alto, California, United States