Efficacy and Safety Study of Binodenoson in Assessing Cardiac Ischemia

Coronary Artery Disease Clinical Trial

— VISION-305  

Official title:

Vasodilator Induced Stress In CONcordance With Adenosine (VISION-305)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00944970
• Other study ID #: MRE0470P-305
• Status: Completed
• Phase: Phase 3
• First received: July 17, 2009
• Last updated: May 24, 2012
• Start date: October 2005
• Est. completion date: December 2006

Study information

• Verified date: May 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 578
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• binodenoson
30-second intravenous injection (bolus) of binodenoson (1.5 mcg/kg) and a 6-minute intravenous infusion of placebo
• adenosine
30-second intravenous injection (bolus) of placebo and a 6-minute intravenous infusion of adenosine (140 mcg/kg/minute)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

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