Efficacy and Safety Study of Binodenoson in Assessing Cardiac Ischemia (VISION-302)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
binodenoson
adenosine
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Coronary artery disease, Angina, Anginal symptoms, Ischemic heart disease, Ischemia, Single photon emission computed tomography, Pharmacologic stress, Myocardial perfusion imaging, typical or atypical anginal symptoms, Suspected coronary artery disease, known coronary artery disease
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
binodenoson then adenosine
adenosine then binodenoson
Arm Description
binodenoson (experimental); adenosine (active comparator)
adenosine (active comparator); binodenoson (experimental)
Outcomes
Primary Outcome Measures
Difference in binodenoson and adenosine reader-generated Summed Difference Scores
Extreme discrepancies in binodenoson and adenosine reader-generated Summed Difference Scores
Secondary Outcome Measures
Categorized reader-generated Summed Difference Scores
Difference in reader-generated Summed Stress Scores
Extreme discrepant reader-generated Summed Stress Scores
Categorized reader-generated Summed Stress Scores
Sensitivity compared to coronary angiography
Specificity compared to coronary angiography
Sensitivity compared to clinical endpoint
Specificity compared to clinical endpoint
Incidence of second- or third-degree AV block
Patient-rated overall symptom bother
Patient preference for pharmacologic stress agent
Incidence of flushing
Patient-rated intensity of flushing
Incidence of chest pain
Patient-rated intensity of chest pain
Incidence of dyspnea
Patient-rated intensity of dyspnea
Incidence of nausea
Patient-rated intensity of nausea
Incidence of headache
Patient-rated intensity of headache
Incidence of abdominal discomfort
Patient-rated intensity of abdominal discomfort
Incidence of dizziness
Patient-rated intensity of dizziness
Overall incidence of adverse events
Peak change in heart rate
Peak change in systolic blood pressure
Peak change in diastolic blood pressure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00944294
Brief Title
Efficacy and Safety Study of Binodenoson in Assessing Cardiac Ischemia
Acronym
VISION-302
Official Title
Vasodilator Induced Stress In CONcordance With Adenosine (VISION-302)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary artery disease, Angina, Anginal symptoms, Ischemic heart disease, Ischemia, Single photon emission computed tomography, Pharmacologic stress, Myocardial perfusion imaging, typical or atypical anginal symptoms, Suspected coronary artery disease, known coronary artery disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
419 (Actual)
8. Arms, Groups, and Interventions
Arm Title
binodenoson then adenosine
Arm Type
Other
Arm Description
binodenoson (experimental); adenosine (active comparator)
Arm Title
adenosine then binodenoson
Arm Type
Other
Arm Description
adenosine (active comparator); binodenoson (experimental)
Intervention Type
Drug
Intervention Name(s)
binodenoson
Other Intervention Name(s)
CorVue
Intervention Description
30-second intravenous injection (bolus) of binodenoson (1.5 mcg/kg) and a 6-minute intravenous infusion of placebo
Intervention Type
Drug
Intervention Name(s)
adenosine
Intervention Description
30-second intravenous injection (bolus) of placebo and a 6-minute intravenous infusion of adenosine (140 mcg/kg/minute)
Primary Outcome Measure Information:
Title
Difference in binodenoson and adenosine reader-generated Summed Difference Scores
Time Frame
2 to 7 days apart
Title
Extreme discrepancies in binodenoson and adenosine reader-generated Summed Difference Scores
Time Frame
2 to 7 days apart
Secondary Outcome Measure Information:
Title
Categorized reader-generated Summed Difference Scores
Time Frame
2 to 7 days apart
Title
Difference in reader-generated Summed Stress Scores
Time Frame
2 to 7 days apart
Title
Extreme discrepant reader-generated Summed Stress Scores
Time Frame
2 to 7 days apart
Title
Categorized reader-generated Summed Stress Scores
Time Frame
2 to 7 days apart
Title
Sensitivity compared to coronary angiography
Time Frame
angiography obtained up to 60 days post-image
Title
Specificity compared to coronary angiography
Time Frame
angiography obtained up to 60 days post-image
Title
Sensitivity compared to clinical endpoint
Time Frame
clinical endpoint obtained up to 60 days post-image
Title
Specificity compared to clinical endpoint
Time Frame
clinical endpoint obtained up to 60 days post-image
Title
Incidence of second- or third-degree AV block
Time Frame
0 to 60 minutes after start of study drug administration
Title
Patient-rated overall symptom bother
Time Frame
1 hour post-dosing
Title
Patient preference for pharmacologic stress agent
Time Frame
1 to 4 days following 2nd procedure
Title
Incidence of flushing
Time Frame
0 to 60 minutes after start of study drug administration
Title
Patient-rated intensity of flushing
Time Frame
0 to 60 minutes after start of study drug administration
Title
Incidence of chest pain
Time Frame
0 to 60 minutes after start of study drug administration
Title
Patient-rated intensity of chest pain
Time Frame
0 to 60 minutes after start of study drug administration
Title
Incidence of dyspnea
Time Frame
0 to 60 minutes after start of study drug administration
Title
Patient-rated intensity of dyspnea
Time Frame
0 to 60 minutes after start of study drug administration
Title
Incidence of nausea
Time Frame
0 to 60 minutes after start of study drug administration
Title
Patient-rated intensity of nausea
Time Frame
0 to 60 minutes after start of study drug administration
Title
Incidence of headache
Time Frame
0 to 60 minutes after start of study drug administration
Title
Patient-rated intensity of headache
Time Frame
0 to 60 minutes after start of study drug administration
Title
Incidence of abdominal discomfort
Time Frame
0 to 60 minutes after start of study drug administration
Title
Patient-rated intensity of abdominal discomfort
Time Frame
0 to 60 minutes after start of study drug administration
Title
Incidence of dizziness
Time Frame
0 to 60 minutes after start of study drug administration
Title
Patient-rated intensity of dizziness
Time Frame
0 to 60 minutes after start of study drug administration
Title
Overall incidence of adverse events
Time Frame
up to 7 days post-dosing
Title
Peak change in heart rate
Time Frame
0 to 60 minutes after start of study drug administration
Title
Peak change in systolic blood pressure
Time Frame
0 to 60 minutes after start of study drug administration
Title
Peak change in diastolic blood pressure
Time Frame
0 to 60 minutes after start of study drug administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert L. Rolleri, Pharm.D.
Organizational Affiliation
King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Study of Binodenoson in Assessing Cardiac Ischemia
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