Efficacy and Safety Study of Binodenoson in Assessing Cardiac Ischemia - Full Text View

Purpose

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.

Condition	Intervention	Phase
Coronary Artery Disease	Drug: binodenoson Drug: adenosine	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Diagnostic
Official Title:	Vasodilator Induced Stress In CONcordance With Adenosine (VISION-302)

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Dizziness and Vertigo

Drug Information available for: Adenosine

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Difference in binodenoson and adenosine reader-generated Summed Difference Scores [ Time Frame: 2 to 7 days apart ] [ Designated as safety issue: No ]
Extreme discrepancies in binodenoson and adenosine reader-generated Summed Difference Scores [ Time Frame: 2 to 7 days apart ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Categorized reader-generated Summed Difference Scores [ Time Frame: 2 to 7 days apart ] [ Designated as safety issue: No ]
Difference in reader-generated Summed Stress Scores [ Time Frame: 2 to 7 days apart ] [ Designated as safety issue: No ]
Extreme discrepant reader-generated Summed Stress Scores [ Time Frame: 2 to 7 days apart ] [ Designated as safety issue: No ]
Categorized reader-generated Summed Stress Scores [ Time Frame: 2 to 7 days apart ] [ Designated as safety issue: No ]
Sensitivity compared to coronary angiography [ Time Frame: angiography obtained up to 60 days post-image ] [ Designated as safety issue: No ]
Specificity compared to coronary angiography [ Time Frame: angiography obtained up to 60 days post-image ] [ Designated as safety issue: No ]
Sensitivity compared to clinical endpoint [ Time Frame: clinical endpoint obtained up to 60 days post-image ] [ Designated as safety issue: No ]
Specificity compared to clinical endpoint [ Time Frame: clinical endpoint obtained up to 60 days post-image ] [ Designated as safety issue: No ]
Incidence of second- or third-degree AV block [ Time Frame: 0 to 60 minutes after start of study drug administration ] [ Designated as safety issue: Yes ]
Patient-rated overall symptom bother [ Time Frame: 1 hour post-dosing ] [ Designated as safety issue: Yes ]
Patient preference for pharmacologic stress agent [ Time Frame: 1 to 4 days following 2nd procedure ] [ Designated as safety issue: Yes ]
Incidence of flushing [ Time Frame: 0 to 60 minutes after start of study drug administration ] [ Designated as safety issue: Yes ]
Patient-rated intensity of flushing [ Time Frame: 0 to 60 minutes after start of study drug administration ] [ Designated as safety issue: Yes ]
Incidence of chest pain [ Time Frame: 0 to 60 minutes after start of study drug administration ] [ Designated as safety issue: Yes ]
Patient-rated intensity of chest pain [ Time Frame: 0 to 60 minutes after start of study drug administration ] [ Designated as safety issue: Yes ]
Incidence of dyspnea [ Time Frame: 0 to 60 minutes after start of study drug administration ] [ Designated as safety issue: Yes ]
Patient-rated intensity of dyspnea [ Time Frame: 0 to 60 minutes after start of study drug administration ] [ Designated as safety issue: Yes ]
Incidence of nausea [ Time Frame: 0 to 60 minutes after start of study drug administration ] [ Designated as safety issue: Yes ]
Patient-rated intensity of nausea [ Time Frame: 0 to 60 minutes after start of study drug administration ] [ Designated as safety issue: Yes ]
Incidence of headache [ Time Frame: 0 to 60 minutes after start of study drug administration ] [ Designated as safety issue: Yes ]
Patient-rated intensity of headache [ Time Frame: 0 to 60 minutes after start of study drug administration ] [ Designated as safety issue: Yes ]
Incidence of abdominal discomfort [ Time Frame: 0 to 60 minutes after start of study drug administration ] [ Designated as safety issue: Yes ]
Patient-rated intensity of abdominal discomfort [ Time Frame: 0 to 60 minutes after start of study drug administration ] [ Designated as safety issue: Yes ]
Incidence of dizziness [ Time Frame: 0 to 60 minutes after start of study drug administration ] [ Designated as safety issue: Yes ]
Patient-rated intensity of dizziness [ Time Frame: 0 to 60 minutes after start of study drug administration ] [ Designated as safety issue: Yes ]
Overall incidence of adverse events [ Time Frame: up to 7 days post-dosing ] [ Designated as safety issue: Yes ]
Peak change in heart rate [ Time Frame: 0 to 60 minutes after start of study drug administration ] [ Designated as safety issue: Yes ]
Peak change in systolic blood pressure [ Time Frame: 0 to 60 minutes after start of study drug administration ] [ Designated as safety issue: Yes ]
Peak change in diastolic blood pressure [ Time Frame: 0 to 60 minutes after start of study drug administration ] [ Designated as safety issue: Yes ]

Enrollment:	419
Study Start Date:	February 2004
Study Completion Date:	April 2006
Primary Completion Date:	April 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: CorVue Drug: adenosine 30-second intravenous injection (bolus) of placebo and a 6-minute intravenous infusion of adenosine (140 mcg/kg/minute)
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 Name: CorVue Drug: adenosine 30-second intravenous injection (bolus) of placebo and a 6-minute intravenous infusion of adenosine (140 mcg/kg/minute)

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00944294

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Robert L. Rolleri, Pharm.D.

King Pharmaceuticals is now a wholly owned subsidiary of Pfizer

More Information

No publications provided

Responsible Party:	Kenneth Sommerville, M.D., Vice President, Clinical Development
ClinicalTrials.gov Identifier:	NCT00944294 History of Changes
Other Study ID Numbers:	MRE0470P-302
Study First Received:	July 17, 2009
Last Updated:	May 24, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

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

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Adenosine
Analgesics

Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on May 23, 2013

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