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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Coronary Artery Disease

Treatments: Drug: adenosine; Drug: binodenoson

Study type: Interventional

Funder types: Industry

Identifiers

NCT00944294

MRE0470P-302

Details and patient eligibility

About

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.

Enrollment: 419 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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419 participants in 2 patient groups

binodenoson then adenosine

Other group

Description:

binodenoson (experimental); adenosine (active comparator)

Treatment:

Drug: binodenoson

Drug: adenosine

adenosine then binodenoson

Other group

Description:

adenosine (active comparator); binodenoson (experimental)

Treatment:

Drug: binodenoson

Drug: adenosine