Coronary Artery DiseasePhase 3VISION-302NCT00944294
Efficacy and Safety Study of Binodenoson in Assessing Cardiac Ischemia
A Phase 3 study testing binodenoson and adenosine in people with Coronary Artery Disease, run by Pfizer.
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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- binodenoson and adenosine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 419 participants
- Where
- No sites listed yet
- Study dates
- Feb 2004to Apr 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand and sign an informed consent form.
Who cannot join
- 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.
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- 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.
About this study
Official title: Vasodilator Induced Stress In CONcordance With Adenosine (VISION-302)
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.
- Conditions
- Coronary Artery Disease
- Being tested
- binodenoson, adenosine
- Keywords
- Coronary artery disease, Angina, Anginal symptoms, Ischemic heart disease, Ischemia, Single photon emission computed tomography, Pharmacologic stress, Myocardial perfusion imaging, typical or atypical anginal symptoms, Suspected coronary artery disease, known coronary artery disease
- Medical subject headings
- Coronary Artery Disease, Angina Pectoris, Myocardial Ischemia, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
binodenosonDrug
Also called CorVue
30-second intravenous injection (bolus) of binodenoson (1.5 mcg/kg) and a 6-minute intravenous infusion of placebo
adenosineDrug
30-second intravenous injection (bolus) of placebo and a 6-minute intravenous infusion of adenosine (140 mcg/kg/minute)
| Study group | Role | What they receive |
|---|---|---|
| binodenoson then adenosine | Other | binodenoson (experimental); adenosine (active comparator) Receives: Drug: binodenoson; Drug: adenosine |
| adenosine then binodenoson | Other | adenosine (active comparator); binodenoson (experimental) Receives: Drug: binodenoson; Drug: adenosine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in binodenoson and adenosine reader-generated Summed Difference Scores
Measured: 2 to 7 days apart
Extreme discrepancies in binodenoson and adenosine reader-generated Summed Difference Scores
Measured: 2 to 7 days apart
Secondary outcomes (29)
Categorized reader-generated Summed Difference Scores
Measured: 2 to 7 days apart
Difference in reader-generated Summed Stress Scores
Measured: 2 to 7 days apart
Extreme discrepant reader-generated Summed Stress Scores
Measured: 2 to 7 days apart
Categorized reader-generated Summed Stress Scores
Measured: 2 to 7 days apart
Sensitivity compared to coronary angiography
Measured: angiography obtained up to 60 days post-image
Specificity compared to coronary angiography
Measured: angiography obtained up to 60 days post-image
Sensitivity compared to clinical endpoint
Measured: clinical endpoint obtained up to 60 days post-image
Specificity compared to clinical endpoint
Measured: clinical endpoint obtained up to 60 days post-image
Incidence of second- or third-degree AV block
Measured: 0 to 60 minutes after start of study drug administration
Patient-rated overall symptom bother
Measured: 1 hour post-dosing
Patient preference for pharmacologic stress agent
Measured: 1 to 4 days following 2nd procedure
Incidence of flushing
Measured: 0 to 60 minutes after start of study drug administration
Patient-rated intensity of flushing
Measured: 0 to 60 minutes after start of study drug administration
Incidence of chest pain
Measured: 0 to 60 minutes after start of study drug administration
Patient-rated intensity of chest pain
Measured: 0 to 60 minutes after start of study drug administration
Incidence of dyspnea
Measured: 0 to 60 minutes after start of study drug administration
Patient-rated intensity of dyspnea
Measured: 0 to 60 minutes after start of study drug administration
Incidence of nausea
Measured: 0 to 60 minutes after start of study drug administration
Patient-rated intensity of nausea
Measured: 0 to 60 minutes after start of study drug administration
Incidence of headache
Measured: 0 to 60 minutes after start of study drug administration
Patient-rated intensity of headache
Measured: 0 to 60 minutes after start of study drug administration
Incidence of abdominal discomfort
Measured: 0 to 60 minutes after start of study drug administration
Patient-rated intensity of abdominal discomfort
Measured: 0 to 60 minutes after start of study drug administration
Incidence of dizziness
Measured: 0 to 60 minutes after start of study drug administration
Patient-rated intensity of dizziness
Measured: 0 to 60 minutes after start of study drug administration
Overall incidence of adverse events
Measured: up to 7 days post-dosing
Peak change in heart rate
Measured: 0 to 60 minutes after start of study drug administration
Peak change in systolic blood pressure
Measured: 0 to 60 minutes after start of study drug administration
Peak change in diastolic blood pressure
Measured: 0 to 60 minutes after start of study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2009 (estimated)
- Study startFeb 2004
- Primary completionApr 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 419 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Robert L. Rolleri, Pharm.D., Study director, King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00944294
- Sponsor's protocol ID
- MRE0470P-302
- Acronym
- VISION-302
- Status last verified
- May 2012
- First submitted
- 17 Jul 2009
- Last updated
- 1 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vasodilator Induced Stress In CONcordance With Adenosine (VISION-302)
- ClinicalTrials.gov ID
- NCT00944294
- Acronym / sponsor ID
- VISION-302 / MRE0470P-302
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, Angina, Anginal symptoms, Ischemic heart disease, Ischemia, Single photon emission computed tomography, Pharmacologic stress, Myocardial perfusion imaging
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 419 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 23 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| binodenoson then adenosine | Other | Drug: binodenoson, Drug: adenosinebinodenoson (experimental); adenosine (active comparator) |
| adenosine then binodenoson | Other | Drug: binodenoson, Drug: adenosineadenosine (active comparator); binodenoson (experimental) |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Able to understand and sign an informed consent form.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| binodenosonAlso: CorVue30-second intravenous injection (bolus) of binodenoson (1.5 mcg/kg) and a 6-minute intravenous infusion of placebo | Drug | adenosine then binodenoson, binodenoson then adenosine |
| adenosine30-second intravenous injection (bolus) of placebo and a 6-minute intravenous infusion of adenosine (140 mcg/kg/minute) | Drug | adenosine then binodenoson, binodenoson then adenosine |
Primary outcome
Difference in binodenoson and adenosine reader-generated Summed Difference Scores
Time frame: 2 to 7 days apart
Extreme discrepancies in binodenoson and adenosine reader-generated Summed Difference Scores
Time frame: 2 to 7 days apart
29 secondary outcomes
Categorized reader-generated Summed Difference Scores
Time frame: 2 to 7 days apart
Difference in reader-generated Summed Stress Scores
Time frame: 2 to 7 days apart
Extreme discrepant reader-generated Summed Stress Scores
Time frame: 2 to 7 days apart
Categorized reader-generated Summed Stress Scores
Time frame: 2 to 7 days apart
Sensitivity compared to coronary angiography
Time frame: angiography obtained up to 60 days post-image
Specificity compared to coronary angiography
Time frame: angiography obtained up to 60 days post-image
Sensitivity compared to clinical endpoint
Time frame: 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
Incidence of second- or third-degree AV block
Time frame: 0 to 60 minutes after start of study drug administration
Patient-rated overall symptom bother
Time frame: 1 hour post-dosing
Patient preference for pharmacologic stress agent
Time frame: 1 to 4 days following 2nd procedure
Incidence of flushing
Time frame: 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
Incidence of chest pain
Time frame: 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
Incidence of dyspnea
Time frame: 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
Incidence of nausea
Time frame: 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
Incidence of headache
Time frame: 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
Incidence of abdominal discomfort
Time frame: 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
Incidence of dizziness
Time frame: 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
Overall incidence of adverse events
Time frame: up to 7 days post-dosing
Peak change in heart rate
Time frame: 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
Peak change in diastolic blood pressure
Time frame: 0 to 60 minutes after start of study drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert L. Rolleri, Pharm.D. study director
King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing binodenoson and adenosine in people with Coronary Artery Disease, run by Pfizer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in binodenoson and adenosine reader-generated Summed Difference Scores (time frame: 2 to 7 days apart). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2012.