Efficacy and Safety Study of Binodenoson in Assessing Cardiac Ischemia

Study Overview
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Brief Summary
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Binodenoson (an experimental drug) and adenosine (an FDA-approved drug that is currently used by doctors) are used to increase blood flow to the heart just like when a person exercises on a treadmill. Using imaging techniques, this increased blood flow can help determine if areas of the heart are not getting enough blood and oxygen during exercise. The purpose of the study is to determine if binodenoson is as good as adenosine in determining if there are areas of the heart not getting enough oxygen when blood flow to the heart is increased.

Official Title
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Vasodilator Induced Stress In CONcordance With Adenosine (VISION-305)

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: binodenoson
* Drug: adenosine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to understand and sign an informed consent form. Exclusion Criteria: Women who are of childbearing potential. Very low likelihood of coronary artery disease (by American Heart Association and American College of Cardiology standards). Documented history of acute myocardial infarction within 30 days. Percutaneous coronary intervention or coronary bypass graft surgery within 3 years, unless typical or atypical anginal symptoms are present. Reactive airway disease or other contraindication that preclude a patient from receiving adenosine. Previous heart transplant or listed to receive a heart transplant. Cardiomyopathy (idiopathic dilated, restrictive, hypertrophic). History of hemodynamically significant supraventricular tachycardia or sustained ventricular tachycardia. Presence of second- or third-degree AV block (in the absence of permanent pacemaker). Left ventricular ejection fraction greater than 35%, known prior to the first imaging procedure. Presence of advanced heart failure, New York Heart Association Class IV. History of vasospastic/Prinzmetal angina. Active (under treatment) cancer (except skin cancers). Inability to discontinue antianginal medications, Aggrenox®, dipyridamole, and xanthine-containing drugs and foods (including caffeine) as required prior to each imaging procedure. Previous participation in a study of binodenoson. Any physical or psychosocial condition that, based on the Investigator's judgment, would prevent the patient from completing the study.

Ages Eligible for Study
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Minimum Age: 30 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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: binodenoson then adenosine<br>binodenoson (experimental); adenosine (active comparator) | Drug: binodenoson<br>* 30-second intravenous injection (bolus) of binodenoson (1.5 mcg/kg) and a 6-minute intravenous infusion of placebo<br>* Other names: CorVue;Drug: adenosine<br>* 30-second intravenous injection (bolus) of placebo and a 6-minute intravenous infusion of adenosine (140 mcg/kg/minute)<br>|
| Other: adenosine then binodenoson<br>adenosine (active comparator); binodenoson (experimental) | Drug: binodenoson<br>* 30-second intravenous injection (bolus) of binodenoson (1.5 mcg/kg) and a 6-minute intravenous infusion of placebo<br>* Other names: CorVue;Drug: adenosine<br>* 30-second intravenous injection (bolus) of placebo and a 6-minute intravenous infusion of adenosine (140 mcg/kg/minute)<br>|
| Active Comparator: adenosine then adenosine<br> | Drug: adenosine<br>* 30-second intravenous injection (bolus) of placebo and a 6-minute intravenous infusion of adenosine (140 mcg/kg/minute)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summed difference in binodenoson and adenosine reader-generated Summed Difference Scores |  | 2 to 7 days apart | 
| Summed difference in adenosine- and adenosine-2 reader-generated Summed Difference Scores |  | 2 to 7 days apart | 
| Extreme discrepancies in binodenoson and adenosine reader-generated Summed Difference Scores |  | 2 to 7 days apart | 
| Extreme discrepancies in adenosine- and adenosine-2 reader-generated Summed Difference Scores |  | 2 to 7 days apart | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Categorized reader-generated Summed Difference Scores (binodenoson and adenosine) |  | 2 to 7 days apart | 
| Categorized reader-generated Summed Difference Scores (adenosine-1 and adenosine-2) |  | 2 to 7 days apart | 
| Difference in reader-generated Summed Stress Scores (binodenoson and adenosine) |  | 2 to 7 days apart | 
| Difference in reader-generated Summed Stress Scores (adenosine-1 and adenosine-2) |  | 2 to 7 days apart | 
| Extreme discrepant reader-generated Summed Stress Scores (binodenoson and adenosine) |  | 2 to 7 days apart | 
| Extreme discrepant reader-generated Summed Stress Scores (adenosine-1 and adenosine-2) |  | 2 to 7 days apart | 
| Categorized reader-generated Summed Stress Scores (binodenoson and adenosine) |  | 2 to 7 days apart | 
| Categorized reader-generated Summed Stress Scores (adenosine-1 and adenosine-2) |  | 2 to 7 days apart | 
| Sensitivity compared to coronary angiography |  | angiography obtained up to 60 days post-image | 
| Specificity compared to coronary angiography |  | angiography obtained up to 60 days post-image | 
| Sensitivity compared to clinical endpoint |  | clinical endpoint obtained up to 60 days post-image | 
| Specificity compared to clinical endpoint |  | clinical endpoint obtained up to 60 days post-image | 
| Incidence of second- or third-degree AV block |  | 0 to 60 minutes after start of study drug administration | 
| Patient-rated overall symptom bother |  | 1 hour post-dosing | 
| Patient preference for pharmacologic stress agent |  | 1 to 4 days following 2nd procedure | 
| Incidence of flushing |  | 0 to 60 minutes after start of study drug administration | 
| Patient-rated intensity of flushing |  | 0 to 60 minutes after start of study drug administration | 
| Incidence of chest pain |  | 0 to 60 minutes after start of study drug administration | 
| Patient-rated intensity of chest pain |  | 0 to 60 minutes after start of study drug administration | 
| Incidence of dyspnea |  | 0 to 60 minutes after start of study drug administration | 
| Patient-rated intensity of dyspnea |  | 0 to 60 minutes after start of study drug administration | 
| Incidence of nausea |  | 0 to 60 minutes after start of study drug administration | 
| Patient-rated intensity of nausea |  | 0 to 60 minutes after start of study drug administration | 
| Incidence of headache |  | 0 to 60 minutes after start of study drug administration | 
| Patient-rated intensity of headache |  | 0 to 60 minutes after start of study drug administration | 
| Incidence of abdominal discomfort |  | 0 to 60 minutes after start of study drug administration | 
| Patient-rated intensity of abdominal discomfort |  | 0 to 60 minutes after start of study drug administration | 
| Incidence of dizziness |  | 0 to 60 minutes after start of study drug administration | 
| Patient-rated intensity of dizziness |  | 0 to 60 minutes after start of study drug administration | 
| Overall incidence of adverse events |  | up to 7 days post-dosing | 
| Peak change in heart rate |  | 0 to 60 minutes after start of study drug administration | 
| Peak change in systolic blood pressure |  | 0 to 60 minutes after start of study drug administration | 
| Peak change in diastolic blood pressure |  | 0 to 60 minutes after start of study drug administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary artery disease, Angina, Anginal symptoms, Ischemic heart disease, Ischemia, Single photon emission computed tomography, Pharmacologic stress, Myocardial perfusion imaging, Suspected coronary artery disease, known coronary artery disease, typical or atypical anginal symptoms