Clinical trial NCT00944970: Efficacy and Safety Study of Binodenoson in Assessing Cardiac Ischemia
Official title: Vasodilator Induced Stress In CONcordance With Adenosine (VISION-305)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Keywords: 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
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-07-23
Enrollment: 578
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Summed difference in binodenoson and adenosine reader-generated Summed Difference Scores
timeFrame: 2 to 7 days apart
measure: Summed difference in adenosine- and adenosine-2 reader-generated Summed Difference Scores
timeFrame: 2 to 7 days apart
measure: Extreme discrepancies in binodenoson and adenosine reader-generated Summed Difference Scores
timeFrame: 2 to 7 days apart
measure: Extreme discrepancies in adenosine- and adenosine-2 reader-generated Summed Difference Scores
timeFrame: 2 to 7 days apart
Secondary outcomes:
measure: Categorized reader-generated Summed Difference Scores (binodenoson and adenosine)
timeFrame: 2 to 7 days apart
measure: Categorized reader-generated Summed Difference Scores (adenosine-1 and adenosine-2)
timeFrame: 2 to 7 days apart
measure: Difference in reader-generated Summed Stress Scores (binodenoson and adenosine)
timeFrame: 2 to 7 days apart
measure: Difference in reader-generated Summed Stress Scores (adenosine-1 and adenosine-2)
timeFrame: 2 to 7 days apart
measure: Extreme discrepant reader-generated Summed Stress Scores (binodenoson and adenosine)
timeFrame: 2 to 7 days apart
measure: Extreme discrepant reader-generated Summed Stress Scores (adenosine-1 and adenosine-2)
timeFrame: 2 to 7 days apart
measure: Categorized reader-generated Summed Stress Scores (binodenoson and adenosine)
timeFrame: 2 to 7 days apart
measure: Categorized reader-generated Summed Stress Scores (adenosine-1 and adenosine-2)
timeFrame: 2 to 7 days apart
measure: Sensitivity compared to coronary angiography
timeFrame: angiography obtained up to 60 days post-image
measure: Specificity compared to coronary angiography
timeFrame: angiography obtained up to 60 days post-image
measure: Sensitivity compared to clinical endpoint
timeFrame: clinical endpoint obtained up to 60 days post-image
measure: Specificity compared to clinical endpoint
timeFrame: clinical endpoint obtained up to 60 days post-image
measure: Incidence of second- or third-degree AV block
timeFrame: 0 to 60 minutes after start of study drug administration
measure: Patient-rated overall symptom bother
timeFrame: 1 hour post-dosing
measure: Patient preference for pharmacologic stress agent
timeFrame: 1 to 4 days following 2nd procedure
measure: Incidence of flushing
timeFrame: 0 to 60 minutes after start of study drug administration
measure: Patient-rated intensity of flushing
timeFrame: 0 to 60 minutes after start of study drug administration
measure: Incidence of chest pain
timeFrame: 0 to 60 minutes after start of study drug administration
measure: Patient-rated intensity of chest pain
timeFrame: 0 to 60 minutes after start of study drug administration
measure: Incidence of dyspnea
timeFrame: 0 to 60 minutes after start of study drug administration
measure: Patient-rated intensity of dyspnea
timeFrame: 0 to 60 minutes after start of study drug administration
measure: Incidence of nausea
timeFrame: 0 to 60 minutes after start of study drug administration
measure: Patient-rated intensity of nausea
timeFrame: 0 to 60 minutes after start of study drug administration
measure: Incidence of headache
timeFrame: 0 to 60 minutes after start of study drug administration
measure: Patient-rated intensity of headache
timeFrame: 0 to 60 minutes after start of study drug administration
measure: Incidence of abdominal discomfort
timeFrame: 0 to 60 minutes after start of study drug administration
measure: Patient-rated intensity of abdominal discomfort
timeFrame: 0 to 60 minutes after start of study drug administration
measure: Incidence of dizziness
timeFrame: 0 to 60 minutes after start of study drug administration
measure: Patient-rated intensity of dizziness
timeFrame: 0 to 60 minutes after start of study drug administration
measure: Overall incidence of adverse events
timeFrame: up to 7 days post-dosing
measure: Peak change in heart rate
timeFrame: 0 to 60 minutes after start of study drug administration
measure: Peak change in systolic blood pressure
timeFrame: 0 to 60 minutes after start of study drug administration
measure: Peak change in diastolic blood pressure
timeFrame: 0 to 60 minutes after start of study drug administration
Other outcomes:
Locations:
Study officials:
affiliation: King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
name: Robert L. Rolleri, Pharm.D.
role: STUDY_DIRECTOR
References: