Coronary Artery Disease (CAD)
Conditions
Keywords
pharmacologic stress, ischemia, coronary artery disease (CAD)
Brief summary
Observe whether the administration of caffeine prior to regadenoson will affect the interpretation of test results in subjects with coronary artery disease (CAD) undergoing SPECT MPI
Detailed description
All subjects will undergo rest and stress scans. Those subjects who qualify by demonstrating at least 1 reversible defect, will undergo a third scan. All stress scans will involve the injection of regadenoson as the pharmacologic stress agent. Prior to the third scan, the subject will be administered blinded capsules of placebo or caffeine.
Interventions
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject must have undergone a previous diagnostic study \[e.g., SPECT, echocardiography, magnetic resonance imaging (MRI), etc.\] for a clinical indication demonstrating evidence of reversible defects in ≥ 1 vascular segment, have had other stress testing within the past 3 months, or the subject's history suggests at least a 50% likelihood of CAD * If the previous diagnostic study shows only 1 reversible defect and it is in segment 17, another reversible defect will need to be present * Subject with CAD must have an intermediate/low-risk for immediate intervention * Subject must ingest caffeinated food or beverages regularly (at least the equivalent of one cup of caffeinated coffee daily) * Subject must agree to not ingest any caffeine or other foods containing methylxanthine at least 24 hours prior to each study visit * Subject must agree to abstain from eating solid food or drinking liquids other than water for at least 30 minutes prior to each study visit and 30 minutes following each study visit
Exclusion criteria
* Subject with documented myocardial infarction (MI) ≤ 30 days prior to enrollment * Subject with history of percutaneous coronary intervention (PCI) ≤ 4 weeks prior to enrollment * Subject with history of coronary artery bypass graft (CABG) ≤ 8 weeks prior to enrollment * Subject has prior history of heart transplantation * Subject has unstable angina, known severe left main coronary artery stenosis, severe heart failure, uncontrolled arrhythmias, symptomatic hypotension or severe hypertension (systolic blood pressure \< 90 or \> 180 mmHg, respectively), or \> 1st degree atrioventricular block in the absence of a functioning pacemaker * Subject requires emergent cardiac medical intervention or catheterization * Subject has a history of smoking, regardless of frequency, tobacco type or method of intake, or using any smoking cessation products, including but not limited to the nicotine patch or nicotine gum, within 3 months prior to first dose of regadenoson * Subject is currently undergoing treatment with theophylline, or theophylline containing medications within 7 days prior to randomization (Day 3) * Subject has a history of known or suspected bronchoconstrictive or bronchospastic lung disease \[e.g., asthma, wheezing, chronic obstructive pulmonary disease (COPD), etc.\] * Subject has a history of diabetes associated with gastric disorders and/or emptying * Subject has end stage renal disease (ESRD) with a GFR\< 15mL/min or currently undergoing dialysis for ESRD
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Number of Reversible Defects | Day 3 and Day 5 | Each segment of the 17-Segment Model was assessed for radiotracer uptake on a scale of 0 (normal uptake) to 4 (absent uptake). Segments were counted as having a reversible defect if the stress score was greater than the rest score and the stress score was ≥ 2. Change was calculated as the number of reversible defects using regadenoson with caffeine/placebo (Day 5) minus the number of reversible defects using regadenoson alone (Day 3). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Number of Reversible Defects Assessed by Computerized Quantitation | Day 3 and Day 5 | Each segment of the 17-Segment Model was assessed for radiotracer uptake on a scale of 0 (normal uptake) to 4 (absent uptake). Segments were counted as having a reversible defect if the stress score was greater than the rest score and the stress score was ≥ 2. Change was calculated as the number of reversible defects using regadenoson with caffeine/placebo (Day 5) minus the number of reversible defects using regadenoson alone (Day 3). |
| Change in Summed Difference Score Across All 17 Segments Assessed by Computerized Quantitation | Day 3 and Day 5 | The Summed Difference Score was calculated as the difference in the Summed Stress Score across the 17 segments (scan run under stress condition) minus the Summed Rest Score across the 17 segments (scan run under rest conditions). Change in SDS was calculated as the SDS for regadenoson with caffeine/placebo stress scan (Day 5) minus the SDS for regadenoson only stress scan (Day 3). The full range of the SDS is -68 to 68, where 0 represents no change between Summed Stress Score and Summed Rest Score. A higher positive score indicates more severe coronary artery disease (CAD). |
| Change in Summed Difference Score (SDS) Across All 17 Segments | Day 3 and Day 5 | The Summed Difference Score was calculated as the difference in the Summed Stress Score across the 17 segments (scan run under stress condition) minus the Summed Rest Score across the 17 segments (scan run under rest conditions). Change in SDS was calculated as the SDS for regadenoson with caffeine/placebo stress scan (Day 5) minus the SDS for regadenoson only stress scan (Day 3). The full range of the SDS is -68 to 68, where 0 represents no change between Summed Stress Score and Summed Rest Score. A higher positive score indicates more severe coronary artery disease (CAD). |
| Change From Baseline in Systolic Blood Pressure | Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min) | Baseline is the last non-missing measurement on or before first dose of regadenoson. Change is calculated as the time point minus baseline. |
| Change From Baseline in Diastolic Blood Pressure | Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min) | Baseline is the last non-missing measurement on or before first dose of regadenoson. Change is calculated as the time point minus baseline. |
| Change From Baseline in Heart Rate | Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min) | Baseline is the last non-missing measurement on or before first dose of regadenoson Change is calculated as the time point minus baseline. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Plus Regadenoson Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection | 66 |
| Caffeine 200 mg Plus Regadenoson One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection | 70 |
| Caffeine 400 mg Plus Regadenoson Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection | 71 |
| Total | 207 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 3 | 0 |
| Overall Study | Interpretation Failure | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 |
| Overall Study | Machine Failure | 1 | 1 | 0 |
| Overall Study | One or more non-interpretable scan | 0 | 1 | 1 |
| Overall Study | Randomized but drug not received | 1 | 0 | 1 |
| Overall Study | Reversible ischemic defect not present | 43 | 40 | 44 |
| Overall Study | Sponsor discontinued subject or study | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Caffeine 200 mg Plus Regadenoson | Placebo Plus Regadenoson | Total | Caffeine 400 mg Plus Regadenoson |
|---|---|---|---|---|
| Age, Continuous | 65.7 years STANDARD_DEVIATION 11.11 | 68.0 years STANDARD_DEVIATION 9.99 | 67.7 years STANDARD_DEVIATION 9.91 | 69.4 years STANDARD_DEVIATION 8.23 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 participants | 0 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized Black or African American | 5 participants | 5 participants | 13 participants | 3 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 participants | 0 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized White | 63 participants | 61 participants | 192 participants | 68 participants |
| Sex: Female, Male Female | 12 Participants | 11 Participants | 43 Participants | 20 Participants |
| Sex: Female, Male Male | 58 Participants | 55 Participants | 164 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 82 / 113 | 89 / 116 | 80 / 116 |
| serious Total, serious adverse events | 1 / 113 | 2 / 116 | 2 / 116 |
Outcome results
Primary
Change in Number of Reversible Defects
Each segment of the 17-Segment Model was assessed for radiotracer uptake on a scale of 0 (normal uptake) to 4 (absent uptake). Segments were counted as having a reversible defect if the stress score was greater than the rest score and the stress score was ≥ 2. Change was calculated as the number of reversible defects using regadenoson with caffeine/placebo (Day 5) minus the number of reversible defects using regadenoson alone (Day 3).
Time frame: Day 3 and Day 5
Population: The number of participants analyzed represents Full Analysis Set (FAS), which included all randomized subjects with interpretable Myocardial Perfusion Imaging (MPI) scans. The number of participants per arm is consistent for all categories of the data table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Plus Regadenoson | Change in Number of Reversible Defects | Double-Blind Stress Scan (Day 5) | 0.80 Reversible Defects | Standard Deviation 1.511 |
| Placebo Plus Regadenoson | Change in Number of Reversible Defects | Baseline Stress Scan (Day 3) | 0.67 Reversible Defects | Standard Deviation 1.377 |
| Placebo Plus Regadenoson | Change in Number of Reversible Defects | DoubleBlind - Baseline (Day 5 - Day 3) | 0.12 Reversible Defects | Standard Deviation 0.981 |
| Caffeine 200 mg Plus Regadenoson | Change in Number of Reversible Defects | Double-Blind Stress Scan (Day 5) | 0.40 Reversible Defects | Standard Deviation 0.907 |
| Caffeine 200 mg Plus Regadenoson | Change in Number of Reversible Defects | Baseline Stress Scan (Day 3) | 1.01 Reversible Defects | Standard Deviation 1.452 |
| Caffeine 200 mg Plus Regadenoson | Change in Number of Reversible Defects | DoubleBlind - Baseline (Day 5 - Day 3) | -0.61 Reversible Defects | Standard Deviation 1.097 |
| Caffeine 400 mg Plus Regadenoson | Change in Number of Reversible Defects | Baseline Stress Scan (Day 3) | 1.00 Reversible Defects | Standard Deviation 1.595 |
| Caffeine 400 mg Plus Regadenoson | Change in Number of Reversible Defects | DoubleBlind - Baseline (Day 5 - Day 3) | -0.62 Reversible Defects | Standard Deviation 1.367 |
| Caffeine 400 mg Plus Regadenoson | Change in Number of Reversible Defects | Double-Blind Stress Scan (Day 5) | 0.38 Reversible Defects | Standard Deviation 0.962 |
Comparison: P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.p-value: <0.001ANCOVA
Comparison: P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.p-value: <0.001ANCOVA
Comparison: P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.p-value: <0.001ANCOVA
Comparison: P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.p-value: 0.9328ANCOVA
Secondary
Change From Baseline in Diastolic Blood Pressure
Baseline is the last non-missing measurement on or before first dose of regadenoson. Change is calculated as the time point minus baseline.
Time frame: Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min)
Population: The number of participants analyzed per arm represents Safety Analysis Set (SAF) all randomized patients who received at least one dose of regadenoson. The number of participants included in the calculation for each visit is noted in the category titles, as N.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo Plus Regadenoson | Change From Baseline in Diastolic Blood Pressure | Change at Day 5 (+ 3 min) [N=67; 70; 72] | -1.0 mmHg |
| Placebo Plus Regadenoson | Change From Baseline in Diastolic Blood Pressure | Change at Day 5 (+15 min) [N=66; 72; 72] | -2.0 mmHg |
| Placebo Plus Regadenoson | Change From Baseline in Diastolic Blood Pressure | Baseline [N= 113; 116;116] | 78.0 mmHg |
| Placebo Plus Regadenoson | Change From Baseline in Diastolic Blood Pressure | Change at Day 5 (- 3 min) [N=67; 70; 71] | 0.0 mmHg |
| Caffeine 200 mg Plus Regadenoson | Change From Baseline in Diastolic Blood Pressure | Change at Day 5 (- 3 min) [N=67; 70; 71] | 4.0 mmHg |
| Caffeine 200 mg Plus Regadenoson | Change From Baseline in Diastolic Blood Pressure | Change at Day 5 (+ 3 min) [N=67; 70; 72] | 4.0 mmHg |
| Caffeine 200 mg Plus Regadenoson | Change From Baseline in Diastolic Blood Pressure | Change at Day 5 (+15 min) [N=66; 72; 72] | 3.0 mmHg |
| Caffeine 200 mg Plus Regadenoson | Change From Baseline in Diastolic Blood Pressure | Baseline [N= 113; 116;116] | 74.0 mmHg |
| Caffeine 400 mg Plus Regadenoson | Change From Baseline in Diastolic Blood Pressure | Change at Day 5 (+15 min) [N=66; 72; 72] | 4.0 mmHg |
| Caffeine 400 mg Plus Regadenoson | Change From Baseline in Diastolic Blood Pressure | Change at Day 5 (+ 3 min) [N=67; 70; 72] | 3.0 mmHg |
| Caffeine 400 mg Plus Regadenoson | Change From Baseline in Diastolic Blood Pressure | Change at Day 5 (- 3 min) [N=67; 70; 71] | 6.0 mmHg |
| Caffeine 400 mg Plus Regadenoson | Change From Baseline in Diastolic Blood Pressure | Baseline [N= 113; 116;116] | 73.0 mmHg |
Secondary
Change From Baseline in Heart Rate
Baseline is the last non-missing measurement on or before first dose of regadenoson Change is calculated as the time point minus baseline.
Time frame: Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min)
Population: The number of participants analyzed per arm represents Safety Analysis Set (SAF) all randomized patients who received at least one dose of regadenoson. The number of participants included in the calculation for each visit is noted in the category titles, as N.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo Plus Regadenoson | Change From Baseline in Heart Rate | Baseline [N=113; 116; 116] | 66.0 Beats per minute |
| Placebo Plus Regadenoson | Change From Baseline in Heart Rate | Change at Day 5 (- 3 min) [N=67; 70; 71] | -2.0 Beats per minute |
| Placebo Plus Regadenoson | Change From Baseline in Heart Rate | Change at Day 5 (+3 min) [N=67; 70; 72] | 9.0 Beats per minute |
| Placebo Plus Regadenoson | Change From Baseline in Heart Rate | Change at Day 5 (+15 min) [N=66; 72; 72] | 4.0 Beats per minute |
| Caffeine 200 mg Plus Regadenoson | Change From Baseline in Heart Rate | Change at Day 5 (+15 min) [N=66; 72; 72] | 1.0 Beats per minute |
| Caffeine 200 mg Plus Regadenoson | Change From Baseline in Heart Rate | Baseline [N=113; 116; 116] | 62.0 Beats per minute |
| Caffeine 200 mg Plus Regadenoson | Change From Baseline in Heart Rate | Change at Day 5 (+3 min) [N=67; 70; 72] | 5.0 Beats per minute |
| Caffeine 200 mg Plus Regadenoson | Change From Baseline in Heart Rate | Change at Day 5 (- 3 min) [N=67; 70; 71] | -1.0 Beats per minute |
| Caffeine 400 mg Plus Regadenoson | Change From Baseline in Heart Rate | Change at Day 5 (+15 min) [N=66; 72; 72] | -1.0 Beats per minute |
| Caffeine 400 mg Plus Regadenoson | Change From Baseline in Heart Rate | Change at Day 5 (- 3 min) [N=67; 70; 71] | -2.0 Beats per minute |
| Caffeine 400 mg Plus Regadenoson | Change From Baseline in Heart Rate | Change at Day 5 (+3 min) [N=67; 70; 72] | 0.0 Beats per minute |
| Caffeine 400 mg Plus Regadenoson | Change From Baseline in Heart Rate | Baseline [N=113; 116; 116] | 64.0 Beats per minute |
Secondary
Change From Baseline in Systolic Blood Pressure
Baseline is the last non-missing measurement on or before first dose of regadenoson. Change is calculated as the time point minus baseline.
Time frame: Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min)
Population: The number of participants analyzed per arm represents Safety Analysis Set (SAF) all randomized patients who received at least one dose of regadenoson. The number of participants included in the calculation for each visit is noted in the category titles, as N.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo Plus Regadenoson | Change From Baseline in Systolic Blood Pressure | Baseline [N=113; 116; 116] | 135.0 mmHg |
| Placebo Plus Regadenoson | Change From Baseline in Systolic Blood Pressure | Change at Day 5 (- 3 min) [N=67;70;71] | 0.0 mmHg |
| Placebo Plus Regadenoson | Change From Baseline in Systolic Blood Pressure | Change at Day 5 (+3 min) [N=67; 70; 72] | 0.0 mmHg |
| Placebo Plus Regadenoson | Change From Baseline in Systolic Blood Pressure | Change at Day 5 (+15 min) [N=66; 72; 72] | -2.0 mmHg |
| Caffeine 200 mg Plus Regadenoson | Change From Baseline in Systolic Blood Pressure | Change at Day 5 (+15 min) [N=66; 72; 72] | 8.0 mmHg |
| Caffeine 200 mg Plus Regadenoson | Change From Baseline in Systolic Blood Pressure | Baseline [N=113; 116; 116] | 131.0 mmHg |
| Caffeine 200 mg Plus Regadenoson | Change From Baseline in Systolic Blood Pressure | Change at Day 5 (+3 min) [N=67; 70; 72] | 8.0 mmHg |
| Caffeine 200 mg Plus Regadenoson | Change From Baseline in Systolic Blood Pressure | Change at Day 5 (- 3 min) [N=67;70;71] | 12.0 mmHg |
| Caffeine 400 mg Plus Regadenoson | Change From Baseline in Systolic Blood Pressure | Change at Day 5 (+15 min) [N=66; 72; 72] | 5.0 mmHg |
| Caffeine 400 mg Plus Regadenoson | Change From Baseline in Systolic Blood Pressure | Change at Day 5 (- 3 min) [N=67;70;71] | 11.0 mmHg |
| Caffeine 400 mg Plus Regadenoson | Change From Baseline in Systolic Blood Pressure | Change at Day 5 (+3 min) [N=67; 70; 72] | 7.5 mmHg |
| Caffeine 400 mg Plus Regadenoson | Change From Baseline in Systolic Blood Pressure | Baseline [N=113; 116; 116] | 135.0 mmHg |
Secondary
Change in Number of Reversible Defects Assessed by Computerized Quantitation
Each segment of the 17-Segment Model was assessed for radiotracer uptake on a scale of 0 (normal uptake) to 4 (absent uptake). Segments were counted as having a reversible defect if the stress score was greater than the rest score and the stress score was ≥ 2. Change was calculated as the number of reversible defects using regadenoson with caffeine/placebo (Day 5) minus the number of reversible defects using regadenoson alone (Day 3).
Time frame: Day 3 and Day 5
Population: The number of participants analyzed per arm represents Full Analysis Set (FAS), all randomized subjects with interpretable MPI scans. The number of participants included in the calculation for each visit is noted in the category titles, as N.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Plus Regadenoson | Change in Number of Reversible Defects Assessed by Computerized Quantitation | DoubleBlind - Baseline (Day 5-Day 3)[N=64; 69; 70] | 0.31 Reversible Defects | Standard Deviation 1.622 |
| Placebo Plus Regadenoson | Change in Number of Reversible Defects Assessed by Computerized Quantitation | Baseline Stress Scan (Day 3) [N=64; 69; 70] | 1.47 Reversible Defects | Standard Deviation 1.927 |
| Placebo Plus Regadenoson | Change in Number of Reversible Defects Assessed by Computerized Quantitation | Double-Blind Stress Scan (Day 5) [N=66; 70; 71] | 1.74 Reversible Defects | Standard Deviation 2.355 |
| Caffeine 200 mg Plus Regadenoson | Change in Number of Reversible Defects Assessed by Computerized Quantitation | DoubleBlind - Baseline (Day 5-Day 3)[N=64; 69; 70] | -0.59 Reversible Defects | Standard Deviation 1.743 |
| Caffeine 200 mg Plus Regadenoson | Change in Number of Reversible Defects Assessed by Computerized Quantitation | Double-Blind Stress Scan (Day 5) [N=66; 70; 71] | 1.46 Reversible Defects | Standard Deviation 1.954 |
| Caffeine 200 mg Plus Regadenoson | Change in Number of Reversible Defects Assessed by Computerized Quantitation | Baseline Stress Scan (Day 3) [N=64; 69; 70] | 2.00 Reversible Defects | Standard Deviation 2.364 |
| Caffeine 400 mg Plus Regadenoson | Change in Number of Reversible Defects Assessed by Computerized Quantitation | DoubleBlind - Baseline (Day 5-Day 3)[N=64; 69; 70] | -0.81 Reversible Defects | Standard Deviation 1.812 |
| Caffeine 400 mg Plus Regadenoson | Change in Number of Reversible Defects Assessed by Computerized Quantitation | Double-Blind Stress Scan (Day 5) [N=66; 70; 71] | 1.42 Reversible Defects | Standard Deviation 1.794 |
| Caffeine 400 mg Plus Regadenoson | Change in Number of Reversible Defects Assessed by Computerized Quantitation | Baseline Stress Scan (Day 3) [N=64; 69; 70] | 2.19 Reversible Defects | Standard Deviation 2.122 |
Comparison: P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.p-value: 0.0037ANCOVA
Comparison: P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.p-value: 0.0089ANCOVA
Comparison: P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.p-value: 0.0016ANCOVA
Comparison: P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.p-value: 0.5654ANCOVA
Secondary
Change in Summed Difference Score Across All 17 Segments Assessed by Computerized Quantitation
The Summed Difference Score was calculated as the difference in the Summed Stress Score across the 17 segments (scan run under stress condition) minus the Summed Rest Score across the 17 segments (scan run under rest conditions). Change in SDS was calculated as the SDS for regadenoson with caffeine/placebo stress scan (Day 5) minus the SDS for regadenoson only stress scan (Day 3). The full range of the SDS is -68 to 68, where 0 represents no change between Summed Stress Score and Summed Rest Score. A higher positive score indicates more severe coronary artery disease (CAD).
Time frame: Day 3 and Day 5
Population: The number of participants analyzed per arm represents Full Analysis Set (FAS), all randomized subjects with interpretable MPI scans. The number of participants included in the calculation for each visit is noted in the category titles, as N.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Plus Regadenoson | Change in Summed Difference Score Across All 17 Segments Assessed by Computerized Quantitation | Double-Blind Stress Scan (Day 5) [N=66; 70; 71] | 4.41 Summed Difference Score | Standard Deviation 4.874 |
| Placebo Plus Regadenoson | Change in Summed Difference Score Across All 17 Segments Assessed by Computerized Quantitation | Baseline Stress Scan (Day 3) [N=64; 69; 70] | 3.34 Summed Difference Score | Standard Deviation 4.383 |
| Placebo Plus Regadenoson | Change in Summed Difference Score Across All 17 Segments Assessed by Computerized Quantitation | DoubleBlind - Baseline (Day 5-Day 3)[N=64; 69; 70] | 1.02 Summed Difference Score | Standard Deviation 3.364 |
| Caffeine 200 mg Plus Regadenoson | Change in Summed Difference Score Across All 17 Segments Assessed by Computerized Quantitation | Double-Blind Stress Scan (Day 5) [N=66; 70; 71] | 3.10 Summed Difference Score | Standard Deviation 4.737 |
| Caffeine 200 mg Plus Regadenoson | Change in Summed Difference Score Across All 17 Segments Assessed by Computerized Quantitation | Baseline Stress Scan (Day 3) [N=64; 69; 70] | 4.46 Summed Difference Score | Standard Deviation 4.604 |
| Caffeine 200 mg Plus Regadenoson | Change in Summed Difference Score Across All 17 Segments Assessed by Computerized Quantitation | DoubleBlind - Baseline (Day 5-Day 3)[N=64; 69; 70] | -1.45 Summed Difference Score | Standard Deviation 3.89 |
| Caffeine 400 mg Plus Regadenoson | Change in Summed Difference Score Across All 17 Segments Assessed by Computerized Quantitation | Baseline Stress Scan (Day 3) [N=64; 69; 70] | 4.29 Summed Difference Score | Standard Deviation 4.314 |
| Caffeine 400 mg Plus Regadenoson | Change in Summed Difference Score Across All 17 Segments Assessed by Computerized Quantitation | DoubleBlind - Baseline (Day 5-Day 3)[N=64; 69; 70] | -1.84 Summed Difference Score | Standard Deviation 3.658 |
| Caffeine 400 mg Plus Regadenoson | Change in Summed Difference Score Across All 17 Segments Assessed by Computerized Quantitation | Double-Blind Stress Scan (Day 5) [N=66; 70; 71] | 2.46 Summed Difference Score | Standard Deviation 3.601 |
Comparison: P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.p-value: <0.001ANCOVA
Comparison: P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.p-value: <0.001ANCOVA
Comparison: P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.p-value: <0.001ANCOVA
Comparison: P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.p-value: 0.4246ANCOVA
Secondary
Change in Summed Difference Score (SDS) Across All 17 Segments
The Summed Difference Score was calculated as the difference in the Summed Stress Score across the 17 segments (scan run under stress condition) minus the Summed Rest Score across the 17 segments (scan run under rest conditions). Change in SDS was calculated as the SDS for regadenoson with caffeine/placebo stress scan (Day 5) minus the SDS for regadenoson only stress scan (Day 3). The full range of the SDS is -68 to 68, where 0 represents no change between Summed Stress Score and Summed Rest Score. A higher positive score indicates more severe coronary artery disease (CAD).
Time frame: Day 3 and Day 5
Population: The number of participants analyzed represents Full Analysis Set (FAS), which included all randomized subjects with interpretable MPI scans. The number of participants per arm is consistent for all categories of the data table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Plus Regadenoson | Change in Summed Difference Score (SDS) Across All 17 Segments | DoubleBlind - Baseline (Day 5 - Day 3) | 0.11 Sum Difference Score | Standard Deviation 2.871 |
| Placebo Plus Regadenoson | Change in Summed Difference Score (SDS) Across All 17 Segments | Double-Blind Stress Scan (Day 5) | 2.36 Sum Difference Score | Standard Deviation 3.247 |
| Placebo Plus Regadenoson | Change in Summed Difference Score (SDS) Across All 17 Segments | Baseline Stress Scan (Day 3) | 2.24 Sum Difference Score | Standard Deviation 3.013 |
| Caffeine 200 mg Plus Regadenoson | Change in Summed Difference Score (SDS) Across All 17 Segments | DoubleBlind - Baseline (Day 5 - Day 3) | -1.03 Sum Difference Score | Standard Deviation 2.071 |
| Caffeine 200 mg Plus Regadenoson | Change in Summed Difference Score (SDS) Across All 17 Segments | Baseline Stress Scan (Day 3) | 2.45 Sum Difference Score | Standard Deviation 2.909 |
| Caffeine 200 mg Plus Regadenoson | Change in Summed Difference Score (SDS) Across All 17 Segments | Double-Blind Stress Scan (Day 5) | 1.42 Sum Difference Score | Standard Deviation 2.091 |
| Caffeine 400 mg Plus Regadenoson | Change in Summed Difference Score (SDS) Across All 17 Segments | Double-Blind Stress Scan (Day 5) | 1.27 Sum Difference Score | Standard Deviation 2.003 |
| Caffeine 400 mg Plus Regadenoson | Change in Summed Difference Score (SDS) Across All 17 Segments | Baseline Stress Scan (Day 3) | 2.53 Sum Difference Score | Standard Deviation 3.086 |
| Caffeine 400 mg Plus Regadenoson | Change in Summed Difference Score (SDS) Across All 17 Segments | DoubleBlind - Baseline (Day 5 - Day 3) | -1.25 Sum Difference Score | Standard Deviation 2.664 |
Comparison: P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.p-value: 0.0011ANCOVA
Comparison: P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.p-value: 0.0034ANCOVA
Comparison: P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.p-value: <0.001ANCOVA
Comparison: P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.p-value: 0.5902ANCOVA