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A 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) (EXERRT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
ClinicalTrials.gov Identifier:
NCT01618669
First received: May 29, 2012
Last updated: January 7, 2016
Last verified: January 2016
Results First Received: December 14, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label
Condition: Coronary Artery Disease (CAD)
Interventions: Drug: Regadenoson
Procedure: Single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was conducted at 49 sites in a total of 3 countries including the United States (44 sites), Argentina (4 sites) and Peru (1 site).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
At Baseline, patients meeting all inclusion/exclusion criteria completed single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) while at rest. Participants then underwent a Bruce or modified Bruce exercise protocol; those unable to reach 85% maximum predicted heart rate and/or 5 metabolic equivalents were randomized.

Reporting Groups
  Description
Regadenoson After Peak Exercise On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT myocardial perfusion imaging (MPI). One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
Regadenoson Alone On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.

Participant Flow:   Overall Study
    Regadenoson After Peak Exercise   Regadenoson Alone
STARTED   578   569 
Received Treatment   575   567 
COMPLETED   544   546 
NOT COMPLETED   34   23 
Lost to Follow-up                1                1 
Randomized but Never Received Study Drug                3                2 
Adverse Event                16                7 
Protocol Violation                5                3 
Withdrawal by Subject                9                9 
Miscellaneous Reason                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants who took at least 1 dose of study drug (Safety Analysis Set).

Reporting Groups
  Description
Regadenoson After Peak Exercise On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
Regadenoson Alone On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
Total Total of all reporting groups

Baseline Measures
   Regadenoson After Peak Exercise   Regadenoson Alone   Total 
Overall Participants Analyzed 
[Units: Participants]
 575   567   1142 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.9  (11.45)   61.9  (11.19)   61.9  (11.32) 
Gender 
[Units: Participants]
     
Female   234   239   473 
Male   341   328   669 
Bruce Exercise Group [1] 
[Units: Participants]
     
Standard Bruce Exercise   448   442   890 
Modified Bruce Exercise   90   93   183 
[1]

The Bruce exercise test involves walking on a treadmill while the heart is monitored by an electrocardiograph. The protocol consists of several stages of progressively greater workloads.

The Modified Bruce protocol starts at a lower workload than the standard test and is typically used for elderly or sedentary patients.

Data are reported for all randomized participants with interpretable SPECT scans at all visits as determined by at least 2 of the 3 blinded independent expert readers (full analysis set; 538 and 534 participants in each treatment group respectively).

Maximum Metabolic Equivalents Achieved [1] 
[Units: Metabolic equivalents]
Mean (Standard Deviation)
 5.45  (2.284)   5.37  (2.331)   5.41  (2.307) 
[1]

A metabolic unit used to quantify the intensity of physical activity, which is defined as the ratio of the metabolic rate during exercise to the metabolic rate at rest. One MET corresponds to an energy expenditure of approximately 1 kcal/kg/hour, or an oxygen uptake of 3.5 ml of O2 consumption/kg/hour.

Data are provided for the full analysis set (538 and 534 participants in each treatment group respectively).



  Outcome Measures
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1.  Primary:   Proportion of Participants With Majority Reader Self-agreement in Ischemia Assessment Between First and Second Stress Scans   [ Time Frame: Day 1 (rest scan and first stress scan) and Day 2 -15 (second stress scan) ]

2.  Secondary:   Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events   [ Time Frame: Within 1 hour for ECG events and up to 24 hours for adverse events after administration of regadenoson ]

3.  Secondary:   Proportion of Participants With Agreement in the Assessment of Absence or Presence of Ischemia Between First and Second Stress Scans   [ Time Frame: Day 1 (stress MPI 1) and Day 2 -15 (stress MPI 2) ]

4.  Secondary:   Proportion of Participants With Agreement in the Assessment of Reversible Defects in 3 Categories of Ischemia Between First and Second Stress Scans   [ Time Frame: Day 1 (stress MPI 1) and Day 2 - 15 (stress MPI 2) ]

5.  Secondary:   Proportion of Participants With Agreement in the Summed Stress Score (SSS) Between First and Second Stress Scans   [ Time Frame: Day 1 (stress MPI 1) and Day 2 - 15 (stress MPI 2) ]

6.  Secondary:   Proportion of Participants With Agreement in the Summed Difference Score (SDS) Between First and Second Stress Scans   [ Time Frame: Day 1 (rest MPI and stress MPI 1) and Day 2 - 15 (stress MPI 2) ]

7.  Secondary:   Participants With Less, the Same, or More Reversible Perfusion Defects Shown by the First Stress Scan When Compared to the Second Stress Scan   [ Time Frame: Day 1 (stress MPI 1) and Day 2-15 (stress MPI 2) ]

8.  Secondary:   Overall Assessment of Image Quality   [ Time Frame: Day 1 (rest MPI and stress MPI 1) and Day 2 - 15 (stress MPI 2) ]

9.  Secondary:   Target to Background Radiotracer Uptake Ratios From the First and Second Stress Scans   [ Time Frame: Day 1 (stress MPI 1) and Day 2 - 15 (stress MPI 2) ]

10.  Secondary:   Percentage of Scans With Subdiaphragmatic Interference   [ Time Frame: Day 1 (stress MPI 1) and Day 2 -15 (stress MPI 2) ]

11.  Secondary:   Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity   [ Time Frame: Day 1 (stress MPI 1) and Day - 15 (stress MPI 2) ]

12.  Secondary:   Number of Participants With Adverse Events Within 24 Hours After Administration of Regadenoson   [ Time Frame: Up to 24 hours after study drug administration for each stress MPI (Day 1 and Day 2-15) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Medical Director, Medical Affairs
Organization: Astellas Pharma Global Development, Inc. (APGD)
e-mail: Astellas.resultsdisclosure@astellas.com



Responsible Party: Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
ClinicalTrials.gov Identifier: NCT01618669     History of Changes
Other Study ID Numbers: 3606-CL-3004
Study First Received: May 29, 2012
Results First Received: December 14, 2015
Last Updated: January 7, 2016
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Peru: Instituto Nacional de Salud
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs