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

May 24, 2012 updated by: Pfizer

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
578

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 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 Names:
  • CorVue
Drug: adenosine
30-second intravenous injection (bolus) of placebo and a 6-minute intravenous infusion of adenosine (140 mcg/kg/minute)
Other: 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 Names:
  • CorVue
Drug: adenosine
30-second intravenous injection (bolus) of placebo and a 6-minute intravenous infusion of adenosine (140 mcg/kg/minute)
Active Comparator: adenosine then adenosine
Drug: adenosine
30-second intravenous injection (bolus) of placebo and a 6-minute intravenous infusion of adenosine (140 mcg/kg/minute)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Extreme discrepancies in binodenoson and adenosine reader-generated Summed Difference Scores
Time Frame: 2 to 7 days apart
2 to 7 days apart
Summed difference in binodenoson and adenosine reader-generated Summed Difference Scores
Time Frame: 2 to 7 days apart
2 to 7 days apart
Summed difference in adenosine- and adenosine-2 reader-generated Summed Difference Scores
Time Frame: 2 to 7 days apart
2 to 7 days apart
Extreme discrepancies in adenosine- and adenosine-2 reader-generated Summed Difference Scores
Time Frame: 2 to 7 days apart
2 to 7 days apart

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Sensitivity compared to coronary angiography
Time Frame: angiography obtained up to 60 days post-image
angiography obtained up to 60 days post-image
Specificity compared to coronary angiography
Time Frame: angiography obtained up to 60 days post-image
angiography obtained up to 60 days post-image
Sensitivity compared to clinical endpoint
Time Frame: clinical endpoint obtained up to 60 days post-image
clinical endpoint obtained up to 60 days post-image
Specificity compared to clinical endpoint
Time Frame: clinical endpoint obtained up to 60 days post-image
clinical endpoint obtained up to 60 days post-image
Incidence of second- or third-degree AV block
Time Frame: 0 to 60 minutes after start of study drug administration
0 to 60 minutes after start of study drug administration
Patient-rated overall symptom bother
Time Frame: 1 hour post-dosing
1 hour post-dosing
Patient preference for pharmacologic stress agent
Time Frame: 1 to 4 days following 2nd procedure
1 to 4 days following 2nd procedure
Incidence of flushing
Time Frame: 0 to 60 minutes after start of study drug administration
0 to 60 minutes after start of study drug administration
Patient-rated intensity of flushing
Time Frame: 0 to 60 minutes after start of study drug administration
0 to 60 minutes after start of study drug administration
Incidence of chest pain
Time Frame: 0 to 60 minutes after start of study drug administration
0 to 60 minutes after start of study drug administration
Patient-rated intensity of chest pain
Time Frame: 0 to 60 minutes after start of study drug administration
0 to 60 minutes after start of study drug administration
Incidence of dyspnea
Time Frame: 0 to 60 minutes after start of study drug administration
0 to 60 minutes after start of study drug administration
Patient-rated intensity of dyspnea
Time Frame: 0 to 60 minutes after start of study drug administration
0 to 60 minutes after start of study drug administration
Incidence of nausea
Time Frame: 0 to 60 minutes after start of study drug administration
0 to 60 minutes after start of study drug administration
Patient-rated intensity of nausea
Time Frame: 0 to 60 minutes after start of study drug administration
0 to 60 minutes after start of study drug administration
Incidence of headache
Time Frame: 0 to 60 minutes after start of study drug administration
0 to 60 minutes after start of study drug administration
Patient-rated intensity of headache
Time Frame: 0 to 60 minutes after start of study drug administration
0 to 60 minutes after start of study drug administration
Incidence of abdominal discomfort
Time Frame: 0 to 60 minutes after start of study drug administration
0 to 60 minutes after start of study drug administration
Patient-rated intensity of abdominal discomfort
Time Frame: 0 to 60 minutes after start of study drug administration
0 to 60 minutes after start of study drug administration
Incidence of dizziness
Time Frame: 0 to 60 minutes after start of study drug administration
0 to 60 minutes after start of study drug administration
Patient-rated intensity of dizziness
Time Frame: 0 to 60 minutes after start of study drug administration
0 to 60 minutes after start of study drug administration
Overall incidence of adverse events
Time Frame: up to 7 days post-dosing
up to 7 days post-dosing
Peak change in heart rate
Time Frame: 0 to 60 minutes after start of study drug administration
0 to 60 minutes after start of study drug administration
Peak change in systolic blood pressure
Time Frame: 0 to 60 minutes after start of study drug administration
0 to 60 minutes after start of study drug administration
Peak change in diastolic blood pressure
Time Frame: 0 to 60 minutes after start of study drug administration
0 to 60 minutes after start of study drug administration
Categorized reader-generated Summed Difference Scores (binodenoson and adenosine)
Time Frame: 2 to 7 days apart
2 to 7 days apart
Categorized reader-generated Summed Difference Scores (adenosine-1 and adenosine-2)
Time Frame: 2 to 7 days apart
2 to 7 days apart
Difference in reader-generated Summed Stress Scores (binodenoson and adenosine)
Time Frame: 2 to 7 days apart
2 to 7 days apart
Difference in reader-generated Summed Stress Scores (adenosine-1 and adenosine-2)
Time Frame: 2 to 7 days apart
2 to 7 days apart
Extreme discrepant reader-generated Summed Stress Scores (binodenoson and adenosine)
Time Frame: 2 to 7 days apart
2 to 7 days apart
Extreme discrepant reader-generated Summed Stress Scores (adenosine-1 and adenosine-2)
Time Frame: 2 to 7 days apart
2 to 7 days apart
Categorized reader-generated Summed Stress Scores (binodenoson and adenosine)
Time Frame: 2 to 7 days apart
2 to 7 days apart
Categorized reader-generated Summed Stress Scores (adenosine-1 and adenosine-2)
Time Frame: 2 to 7 days apart
2 to 7 days apart

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Robert L. Rolleri, Pharm.D., King Pharmaceuticals is now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2006

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2006

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 23, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MRE0470P-305

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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