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| Name | Class |
|---|---|
| Astellas Pharma US, Inc. | INDUSTRY |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Regadenoson |
|
| 2 | Active Comparator | Adenoscan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regadenoson | Drug | 0.4 mg, bolus intravenous injection |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Non-inferiority of regadenoson to Adenoscan for use in single photon emission computed tomography (SPECT) myocardial perfusion imaging in assessing reversible perfusion defects | After radiopharmaceutical administration |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple study locations (see Central Contact); CV Therapeutics, Inc. | Palo Alto | California | 94304 | United States |
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| Label | URL |
|---|---|
| Adenoscan® | View source |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C430916 | regadenoson |
| D000241 | Adenosine |
| ID | Term |
|---|---|
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Adenosine | Drug | 0.14 mg/kg/min for 6 minutes, intravenous infusion |
|
|
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |