Caffeine's Effect on Regadenoson Administration With Single Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00826280
First received: January 21, 2009
Last updated: September 14, 2011
Last verified: September 2011
  Purpose

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


Condition Intervention Phase
Coronary Artery Disease (CAD)
Drug: regadenoson
Drug: overencapsulated caffeine
Radiation: technetium
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: A Phase 3b, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Caffeine Intake on Single Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI) in Subjects Administered Regadenoson

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Change in Number of Reversible Defects [ Time Frame: Day 3 and Day 5 ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • Change in Summed Difference Score (SDS) Across All 17 Segments [ Time Frame: Day 3 and Day 5 ] [ Designated as safety issue: No ]

    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 Number of Reversible Defects Assessed by Computerized Quantitation [ Time Frame: Day 3 and Day 5 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Day 3 and Day 5 ] [ Designated as safety issue: No ]

    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 Heart Rate [ Time Frame: Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min) ] [ Designated as safety issue: No ]

    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 Systolic Blood Pressure [ Time Frame: Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min) ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min) ] [ Designated as safety issue: No ]

    Baseline is the last non-missing measurement on or before first dose of regadenoson.

    Change is calculated as the time point minus baseline.



Enrollment: 347
Study Start Date: March 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo plus Regadenoson
Two placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
Drug: regadenoson
IV
Other Names:
  • CVT 3146
  • Lexiscan
Radiation: technetium
IV
Other Names:
  • sestamibi
  • tetrafosmin
Drug: placebo
oral
Experimental: Caffeine 200 mg plus Regadenoson
One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
Drug: regadenoson
IV
Other Names:
  • CVT 3146
  • Lexiscan
Drug: overencapsulated caffeine
oral
Radiation: technetium
IV
Other Names:
  • sestamibi
  • tetrafosmin
Experimental: Caffeine 400 mg plus Regadenoson
Two 200 mg Caffeine capsules plus 0.4 mg regadenoson per 5mL intravenous bolus injection
Drug: regadenoson
IV
Other Names:
  • CVT 3146
  • Lexiscan
Drug: overencapsulated caffeine
oral
Radiation: technetium
IV
Other Names:
  • sestamibi
  • tetrafosmin

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00826280

  Show 25 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Use Central Contact Astellas Pharma Global Development
  More Information

Additional Information:
No publications provided by Astellas Pharma Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00826280     History of Changes
Other Study ID Numbers: 3606-CL-3002
Study First Received: January 21, 2009
Results First Received: July 8, 2011
Last Updated: September 14, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
coronary artery disease (CAD)
ischemia
pharmacologic stress

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Caffeine
Regadenoson
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Adenosine A2 Receptor Antagonists

ClinicalTrials.gov processed this record on July 26, 2014