Efficacy and Safety Study of Binodenoson in Assessing Cardiac Ischemia (VISION-302)

Vasodilator Induced Stress In CONcordance With Adenosine (VISION-302)

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: binodenoson; Drug: adenosine

• Study Type: Interventional
• Enrollment (Actual): 419
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Difference in binodenoson and adenosine 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

Secondary Outcome Measures

Outcome Measure	Time Frame
Categorized reader-generated Summed Difference Scores	2 to 7 days apart
Difference in reader-generated Summed Stress Scores	2 to 7 days apart
Extreme discrepant reader-generated Summed Stress Scores	2 to 7 days apart
Categorized reader-generated Summed Stress Scores	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

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Robert L. Rolleri, Pharm.D., King Pharmaceuticals is now a wholly owned subsidiary of Pfizer

Study record dates

Study Major Dates

• Study Start: February 1, 2004
• Primary Completion (Actual): April 1, 2006
• Study Completion (Actual): April 1, 2006

Study Registration Dates

• First Submitted: July 17, 2009
• First Submitted That Met QC Criteria: July 22, 2009
• First Posted (Estimate): July 23, 2009

Study Record Updates

• Last Update Posted (Estimate): June 1, 2012
• Last Update Submitted That Met QC Criteria: May 24, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Coronary artery disease; Angina; Ischemia; Single photon emission computed tomography; Ischemic heart disease; Suspected coronary artery disease; Myocardial perfusion imaging; Anginal symptoms; Pharmacologic stress; typical or atypical anginal symptoms; known coronary artery disease
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Vasodilator Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Purinergic Agents; Purinergic P1 Receptor Agonists; Purinergic Agonists; Adenosine; Binodenoson
• Other Study ID Numbers: MRE0470P-302