The ASPECT2 Trial: A Phase 3, Randomized, Double-Blind Trial of Apadenoson for the Detection of Myocardial Perfusion Defects Using Single-Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 197
- 试验地点
- 86
- 主要终点
- Presence of myocardial perfusion defect based on SPECT-MPI
研究概览
简要总结
The purpose of this study is to see whether apadenoson is as effective as adenosine when used as a pharmacological stress agent in myocardial SPECT-imaging (SPECT-MPI)to detect defects in the supply of blood to the heart muscle (myocardial perfusion defects). The study will also look at whether apadenoson is better tolerated than adenosine when used in SPECT-MPI.
详细描述
Adenosine is an effective vasodilator used in SPECT-Myocardial Perfusion Imaging (SPECT-MPI). However, it produces transient symptoms that are poorly tolerated by most subjects. This is a multi-center, randomized double-blind study to compare the tolerability and effectiveness of apadenoson to adenosine (Adenoscan®) in SPECT-MPI. Subjects who are clinical candidates for SPECT-MPI will be enrolled to undergo two sequential SPECT-MPI studies. The first study will use adenosine as the stress agent in approximately 1250 subjects. Eligible subjects will then be randomized in a 1:1 assignment ratio to receive a second SPECT-MPI using either adenosine or apadenoson as the pharmacologic stress agent, with the goal of obtaining a total of 670 subjects who complete both studies. The agreement of the results from the two adenosine:adenosine stress tests will be compared to that from the adenosine:apadenoson tests to assess efficacy. The incidence and intensity of commonly reported side effects will be compared to evaluate improved tolerability.
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, 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 rest/pharmacologic stress SPECT-MPI test
- •High pretest probability (90% or greater) of CAD based on the ACC/AHA guidelines for relative risk, or past medical h/o CAD
排除标准
- •Acute MI, new onset of ischemia or PCI within 30 days prior to SPECT-MPI at either Period 1 or Period 2; or CABG within 90 days prior to SPECT-MPI at either Period 1 or Period 2
- •Active severe asthma or severe chronic obstructive pulmonary disease (COPD) which, in the Investigator's opinion, places the subject at risk for severe bronchoconstriction
- •History or evidence of clinically significant cardiac condition and rhythm disorder, in the absence of a functioning permanently implanted pacemaker
- •Hemodynamically significant valvular disease, outflow tract obstruction, or uncontrolled severe hypertension
- •Known history of cerebral vascular accident or suspected transient ischemic attack within 30 days prior to signed informed consent
- •Current significant medical, surgical, psychiatric, or other illness or pathology that could potentiate any adverse pharmacological event associated with an investigational drug
研究组 & 干预措施
Apadenoson
In period 1, subjects will receive a clinically-indicated rest/stress gated SPECT-MPI with adenosine. In period 2, subjects will receive a rest/stress gated SPECT-MPI with apadenoson
干预措施: Apadenoson SPECT-MPI (Drug)
Apadenoson
In period 1, subjects will receive a clinically-indicated rest/stress gated SPECT-MPI with adenosine. In period 2, subjects will receive a rest/stress gated SPECT-MPI with apadenoson
干预措施: Adenosine SPECT-MPI (Drug)
Adenosine
In period 1, subjects will receive a clinically-indicated rest/stress gated SPECT-MPI with adenosine. In period 2, subjects will receive a rest/stress gated SPECT-MPI with the active comparator: adenosine.
干预措施: Apadenoson SPECT-MPI (Drug)
Adenosine
In period 1, subjects will receive a clinically-indicated rest/stress gated SPECT-MPI with adenosine. In period 2, subjects will receive a rest/stress gated SPECT-MPI with the active comparator: adenosine.
干预措施: Adenosine SPECT-MPI (Drug)
结局指标
主要结局
Presence of myocardial perfusion defect based on SPECT-MPI
时间窗: Up to 2 hours after study drug administration in Period 1 and Period 2
次要结局
- Incidence and subject rated intensity of most commonly reported side effects associated with use of adenosine compared to apadenoson in SPECT-MPI(Up to 2 hours after administration of study drug in Period 2)