At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,147 enrolled
Drug / intervention
Regadenoson +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3b, Open-Label, Parallel Group, Randomized, Multicenter Study to Assess Regadenoson Administration Following an Inadequate Exercise Stress Test as Compared to Regadenoson Alone for Myocardial Perfusion Imaging (MPI) Using Single Photon Emission Computed Tomography (SPECT)
In Brief
A Phase 3 clinical trial evaluating Regadenoson and Single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) for Coronary Artery Disease (CAD). Completed, enrolled 1,147 participants across 69 sites in 4 countries.
Detailed Summary
The purpose of this study is to demonstrate that the strength of agreement between single photon emission computed tomography (SPECT) imaging with regadenoson following inadequate exercise stress testing and SPECT imaging with regadenoson alone is not inferior to the strength of agreement between two sequential regadenoson SPECT images without exercise.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease (CAD)
CountriesArgentina, Peru, Puerto Rico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2012
First PostedJun 2012
Primary CompletionDec 2014
TodayJul 2026
First PostedJun 13, 2012
Enrollment StartJun 1, 2012
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 14.1 years ago
Interventions
Regadenosondrug
Administered as an intravenous (IV) bolus
Single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI)procedure