Efficacy and Safety Study of Binodenoson in Assessing Cardiac Ischemia
Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Artery Disease
Intervention: binodenoson (Drug); adenosine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Robert L. Rolleri, Pharm.D., Study Director, Affiliation: King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
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.
Clinical Details
Official title: Vasodilator Induced Stress In CONcordance With Adenosine (VISION-305)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic
Primary outcome: Summed difference in binodenoson and adenosine reader-generated Summed Difference ScoresSummed difference in adenosine- and adenosine-2 reader-generated Summed Difference Scores Extreme discrepancies in binodenoson and adenosine reader-generated Summed Difference Scores Extreme discrepancies in adenosine- and adenosine-2 reader-generated Summed Difference Scores
Secondary outcome: Categorized reader-generated Summed Difference Scores (binodenoson and adenosine)Categorized reader-generated Summed Difference Scores (adenosine-1 and adenosine-2) Difference in reader-generated Summed Stress Scores (binodenoson and adenosine) Difference in reader-generated Summed Stress Scores (adenosine-1 and adenosine-2) Extreme discrepant reader-generated Summed Stress Scores (binodenoson and adenosine) Extreme discrepant reader-generated Summed Stress Scores (adenosine-1 and adenosine-2) Categorized reader-generated Summed Stress Scores (binodenoson and adenosine) Categorized reader-generated Summed Stress Scores (adenosine-1 and adenosine-2) 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
Eligibility
Minimum age: 30 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: October 2005
Last updated: May 24, 2012
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