ADVANCE MPI 2: Study of Regadenoson Versus Adenoscan® in Patients Undergoing Myocardial Perfusion Imaging (MPI)

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase III, Randomized, Double-Blind Study of Intravenous CVT-3146 Versus Adenoscan® in Patients Undergoing Stress Myocardial Perfusion Imaging

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Regadenoson
* Drug: Adenosine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Regadenoson | Drug: Regadenoson<br>* 0.4 mg, bolus intravenous injection<br>* Other names: CVT-3146;|
| Active Comparator: 2<br>Adenoscan | Drug: Adenosine<br>* 0.14 mg/kg/min for 6 minutes, intravenous infusion<br>* Other names: Adenoscan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-inferiority of regadenoson to Adenoscan for use in SPECT myocardial perfusion imaging in assessing reversible perfusion defects |  | After radiopharmaceutical administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lexiscan, Regadenoson, Adenoscan®, Adenosine, SPECT Myocardial Perfusion Imaging, Reversible Perfusion Defect