A Phase III, Randomized, Double-Blind Study of Intravenous CVT-3146 Versus Adenoscan® in Patients Undergoing Stress Myocardial Perfusion Imaging
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,231
- 试验地点
- 1
- 主要终点
- Non-inferiority of regadenoson to Adenoscan for use in single photon emission computed tomography (SPECT) myocardial perfusion imaging in assessing reversible perfusion defects
研究概览
简要总结
Adenoscan® (adenosine) is an approved pharmacological stress agent indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately. The investigational drug, regadenoson (CVT-3146) is a selective A2A adenosine receptor agonist, the receptor responsible for coronary vasodilation, and is being studied for potential use as a pharmacologic stress agent in myocardial perfusion imaging (MPI) studies. This study will compare the safety and efficacy of regadenoson to that of Adenoscan in detecting reversible myocardial perfusion defects.
详细描述
ADVANCE MPI 1 is a multi-national, double-blind, randomized, active-controlled, parallel group clinical trial to evaluate the safety and efficacy of regadenoson in SPECT MPI compared to that of the approved pharmacological stress agent, Adenoscan. Patients referred for a clinically indicated pharmacological stress MPI study will be eligible for enrollment. The trial is designed:
- to compare the pharmacological stress SPECT images obtained with regadenoson to those obtained with Adenoscan, and
- to compare the safety and tolerability of the two stress agents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Referred for a clinically indicated pharmacological stress SPECT myocardial perfusion imaging study
排除标准
- •Any condition precluding the safe administration of Adenoscan for a SPECT myocardial perfusion imaging study
- •Pregnant or breast-feeding, or (if pre-menopausal), not practicing acceptable method of birth control
研究组 & 干预措施
1
Regadenoson
干预措施: Regadenoson (Drug)
2
Adenoscan
干预措施: Adenosine (Drug)
结局指标
主要结局
Non-inferiority of regadenoson to Adenoscan for use in single photon emission computed tomography (SPECT) myocardial perfusion imaging in assessing reversible perfusion defects
时间窗: After radiopharmaceutical administration
次要结局
- Safety and tolerability comparison of regadenoson to Adenoscan(Up to two weeks)
- Additional comparisons of images obtained with regadenoson to those obtained with Adenoscan(After radiopharmaceutical administration)