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Efficacy and Safety Study of Binodenoson in Assessing Cardiac Ischemia (VISION-305)

Primary Purpose

Coronary Artery Disease

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

binodenoson

adenosine

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Coronary artery disease, Angina, Anginal symptoms, Ischemic heart disease, Ischemia, Single photon emission computed tomography, Pharmacologic stress, Myocardial perfusion imaging, Suspected coronary artery disease, known coronary artery disease, typical or atypical anginal symptoms

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Active Comparator

Arm Label

binodenoson then adenosine

adenosine then binodenoson

adenosine then adenosine

Arm Description

binodenoson (experimental); adenosine (active comparator)

adenosine (active comparator); binodenoson (experimental)

Outcomes

Primary Outcome Measures

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 Measures

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

Full Information

NCT ID

NCT00944970

First Posted

July 17, 2009

Last Updated

May 24, 2012

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00944970

Brief Title

Efficacy and Safety Study of Binodenoson in Assessing Cardiac Ischemia

Acronym

VISION-305

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Completed

Study Start Date

October 2005 (undefined)

Primary Completion Date

December 2006 (Actual)

Study Completion Date

December 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

Coronary artery disease, Angina, Anginal symptoms, Ischemic heart disease, Ischemia, Single photon emission computed tomography, Pharmacologic stress, Myocardial perfusion imaging, Suspected coronary artery disease, known coronary artery disease, typical or atypical anginal symptoms

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

578 (Actual)

8. Arms, Groups, and Interventions

Arm Title

binodenoson then adenosine

Arm Type

Other

Arm Description

binodenoson (experimental); adenosine (active comparator)

Arm Title

adenosine then binodenoson

Arm Type

Other

Arm Description

adenosine (active comparator); binodenoson (experimental)

Arm Title

adenosine then adenosine

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

binodenoson

Other Intervention Name(s)

CorVue

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

adenosine

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

2 to 7 days apart

Title

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

Time Frame

2 to 7 days apart

Title

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

Time Frame

2 to 7 days apart

Title

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

Time Frame

2 to 7 days apart

Secondary Outcome Measure Information:

Title

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

Time Frame

2 to 7 days apart

Title

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

Time Frame

2 to 7 days apart

Title

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

Time Frame

2 to 7 days apart

Title

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

Time Frame

2 to 7 days apart

Title

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

Time Frame

2 to 7 days apart

Title

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

Time Frame

2 to 7 days apart

Title

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

Time Frame

2 to 7 days apart

Title

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

Time Frame

2 to 7 days apart

Title

Sensitivity compared to coronary angiography

Time Frame

angiography obtained up to 60 days post-image

Title

Specificity compared to coronary angiography

Time Frame

angiography obtained up to 60 days post-image

Title

Sensitivity compared to clinical endpoint

Time Frame

clinical endpoint obtained up to 60 days post-image

Title

Specificity compared to clinical endpoint

Time Frame

clinical endpoint obtained up to 60 days post-image

Title

Incidence of second- or third-degree AV block

Time Frame

0 to 60 minutes after start of study drug administration

Title

Patient-rated overall symptom bother

Time Frame

1 hour post-dosing

Title

Patient preference for pharmacologic stress agent

Time Frame

1 to 4 days following 2nd procedure

Title

Incidence of flushing

Time Frame

0 to 60 minutes after start of study drug administration

Title

Patient-rated intensity of flushing

Time Frame

0 to 60 minutes after start of study drug administration

Title

Incidence of chest pain

Time Frame

0 to 60 minutes after start of study drug administration

Title

Patient-rated intensity of chest pain

Time Frame

0 to 60 minutes after start of study drug administration

Title

Incidence of dyspnea

Time Frame

0 to 60 minutes after start of study drug administration

Title

Patient-rated intensity of dyspnea

Time Frame

0 to 60 minutes after start of study drug administration

Title

Incidence of nausea

Time Frame

0 to 60 minutes after start of study drug administration

Title

Patient-rated intensity of nausea

Time Frame

0 to 60 minutes after start of study drug administration

Title

Incidence of headache

Time Frame

0 to 60 minutes after start of study drug administration

Title

Patient-rated intensity of headache

Time Frame

0 to 60 minutes after start of study drug administration

Title

Incidence of abdominal discomfort

Time Frame

0 to 60 minutes after start of study drug administration

Title

Patient-rated intensity of abdominal discomfort

Time Frame

0 to 60 minutes after start of study drug administration

Title

Incidence of dizziness

Time Frame

0 to 60 minutes after start of study drug administration

Title

Patient-rated intensity of dizziness

Time Frame

0 to 60 minutes after start of study drug administration

Title

Overall incidence of adverse events

Time Frame

up to 7 days post-dosing

Title

Peak change in heart rate

Time Frame

0 to 60 minutes after start of study drug administration

Title

Peak change in systolic blood pressure

Time Frame

0 to 60 minutes after start of study drug administration

Title

Peak change in diastolic blood pressure

Time Frame

0 to 60 minutes after start of study drug administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert L. Rolleri, Pharm.D.

Organizational Affiliation

King Pharmaceuticals is now a wholly owned subsidiary of Pfizer

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety Study of Binodenoson in Assessing Cardiac Ischemia

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