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Efficacy and Safety Study of Binodenoson in Assessing Cardiac Ischemia

Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Coronary Artery Disease

Intervention: binodenoson (Drug); adenosine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Robert L. Rolleri, Pharm.D., Study Director, Affiliation: King Pharmaceuticals is now a wholly owned subsidiary of Pfizer

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.

Clinical Details

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

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

Primary outcome:

Summed difference in binodenoson and adenosine reader-generated Summed Difference Scores

Summed difference in adenosine- and adenosine-2 reader-generated Summed Difference Scores

Extreme discrepancies in binodenoson and adenosine reader-generated Summed Difference Scores

Extreme discrepancies in adenosine- and adenosine-2 reader-generated Summed Difference Scores

Secondary outcome:

Categorized reader-generated Summed Difference Scores (binodenoson and adenosine)

Categorized reader-generated Summed Difference Scores (adenosine-1 and adenosine-2)

Difference in reader-generated Summed Stress Scores (binodenoson and adenosine)

Difference in reader-generated Summed Stress Scores (adenosine-1 and adenosine-2)

Extreme discrepant reader-generated Summed Stress Scores (binodenoson and adenosine)

Extreme discrepant reader-generated Summed Stress Scores (adenosine-1 and adenosine-2)

Categorized reader-generated Summed Stress Scores (binodenoson and adenosine)

Categorized reader-generated Summed Stress Scores (adenosine-1 and adenosine-2)

Sensitivity compared to coronary angiography

Specificity compared to coronary angiography

Sensitivity compared to clinical endpoint

Specificity compared to clinical endpoint

Incidence of second- or third-degree AV block

Patient-rated overall symptom bother

Patient preference for pharmacologic stress agent

Incidence of flushing

Patient-rated intensity of flushing

Incidence of chest pain

Patient-rated intensity of chest pain

Incidence of dyspnea

Patient-rated intensity of dyspnea

Incidence of nausea

Patient-rated intensity of nausea

Incidence of headache

Patient-rated intensity of headache

Incidence of abdominal discomfort

Patient-rated intensity of abdominal discomfort

Incidence of dizziness

Patient-rated intensity of dizziness

Overall incidence of adverse events

Peak change in heart rate

Peak change in systolic blood pressure

Peak change in diastolic blood pressure

Eligibility

Minimum age: 30 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Additional Information

Starting date: October 2005
Last updated: May 24, 2012

Page last updated: August 20, 2015

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