NCT00944970已完成3 期
Vasodilator Induced Stress In CONcordance With Adenosine (VISION-305)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 578
- 主要终点
- Summed difference in binodenoson and adenosine reader-generated Summed Difference Scores
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand and sign an informed consent form.
排除标准
- •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.
研究组 & 干预措施
binodenoson then adenosine
Other
binodenoson (experimental); adenosine (active comparator)
干预措施: binodenoson (Drug)
binodenoson then adenosine
Other
binodenoson (experimental); adenosine (active comparator)
干预措施: adenosine (Drug)
adenosine then binodenoson
Other
adenosine (active comparator); binodenoson (experimental)
干预措施: binodenoson (Drug)
adenosine then binodenoson
Other
adenosine (active comparator); binodenoson (experimental)
干预措施: adenosine (Drug)
adenosine then adenosine
Active Comparator
干预措施: adenosine (Drug)
结局指标
主要结局
Summed difference in binodenoson and adenosine reader-generated Summed Difference Scores
时间窗: 2 to 7 days apart
Summed difference in adenosine- and adenosine-2 reader-generated Summed Difference Scores
时间窗: 2 to 7 days apart
Extreme discrepancies in binodenoson and adenosine reader-generated Summed Difference Scores
时间窗: 2 to 7 days apart
Extreme discrepancies in adenosine- and adenosine-2 reader-generated Summed Difference Scores
时间窗: 2 to 7 days apart
次要结局
- Categorized reader-generated Summed Difference Scores (binodenoson and adenosine)(2 to 7 days apart)
- Categorized reader-generated Summed Difference Scores (adenosine-1 and adenosine-2)(2 to 7 days apart)
- Difference in reader-generated Summed Stress Scores (binodenoson and adenosine)(2 to 7 days apart)
- Difference in reader-generated Summed Stress Scores (adenosine-1 and adenosine-2)(2 to 7 days apart)
- Extreme discrepant reader-generated Summed Stress Scores (binodenoson and adenosine)(2 to 7 days apart)
- Extreme discrepant reader-generated Summed Stress Scores (adenosine-1 and adenosine-2)(2 to 7 days apart)
- Categorized reader-generated Summed Stress Scores (binodenoson and adenosine)(2 to 7 days apart)
- Categorized reader-generated Summed Stress Scores (adenosine-1 and adenosine-2)(2 to 7 days apart)
- Sensitivity compared to coronary angiography(angiography obtained up to 60 days post-image)
- Specificity compared to coronary angiography(angiography obtained up to 60 days post-image)
- Sensitivity compared to clinical endpoint(clinical endpoint obtained up to 60 days post-image)
- Specificity compared to clinical endpoint(clinical endpoint obtained up to 60 days post-image)
- Incidence of second- or third-degree AV block(0 to 60 minutes after start of study drug administration)
- Patient-rated overall symptom bother(1 hour post-dosing)
- Patient preference for pharmacologic stress agent(1 to 4 days following 2nd procedure)
- Incidence of flushing(0 to 60 minutes after start of study drug administration)
- Patient-rated intensity of flushing(0 to 60 minutes after start of study drug administration)
- Incidence of chest pain(0 to 60 minutes after start of study drug administration)
- Patient-rated intensity of chest pain(0 to 60 minutes after start of study drug administration)
- Incidence of dyspnea(0 to 60 minutes after start of study drug administration)
- Patient-rated intensity of dyspnea(0 to 60 minutes after start of study drug administration)
- Incidence of nausea(0 to 60 minutes after start of study drug administration)
- Patient-rated intensity of nausea(0 to 60 minutes after start of study drug administration)
- Incidence of headache(0 to 60 minutes after start of study drug administration)
- Patient-rated intensity of headache(0 to 60 minutes after start of study drug administration)
- Incidence of abdominal discomfort(0 to 60 minutes after start of study drug administration)
- Patient-rated intensity of abdominal discomfort(0 to 60 minutes after start of study drug administration)
- Incidence of dizziness(0 to 60 minutes after start of study drug administration)
- Patient-rated intensity of dizziness(0 to 60 minutes after start of study drug administration)
- Overall incidence of adverse events(up to 7 days post-dosing)
- Peak change in heart rate(0 to 60 minutes after start of study drug administration)
- Peak change in systolic blood pressure(0 to 60 minutes after start of study drug administration)
- Peak change in diastolic blood pressure(0 to 60 minutes after start of study drug administration)
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