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

November 12, 2024 updated by: Astellas Pharma Inc

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
347

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
      • Huntsville, Alabama, United States, 35801
    • California
      • La Mesa, California, United States, 91942
      • Mission Viejo, California, United States, 92691
      • Roseville, California, United States, 95661
      • Sacramento, California, United States, 95819
      • Santa Rosa, California, United States, 95405
    • Connecticut
      • Hartford, Connecticut, United States, 06102-5037
    • Delaware
      • Newark, Delaware, United States, 19173
    • Florida
      • Jacksonville, Florida, United States, 32216
      • Miami, Florida, United States, 33173
      • Tamarac, Florida, United States, 33321
    • Illinois
      • Aurora, Illinois, United States, 60504
    • Kansas
      • Overland Park, Kansas, United States, 66209
    • Maine
      • Auburn, Maine, United States, 04210
    • Massachusetts
      • Pittsfield, Massachusetts, United States, 01201
    • Michigan
      • Detroit, Michigan, United States, 48202
      • Ypsilanti, Michigan, United States, 48197
    • Missouri
      • Kansas City, Missouri, United States, 64111
    • New York
      • Albany, New York, United States, 12205
      • Rochester, New York, United States, 14642-8679
    • Ohio
      • Columbus, Ohio, United States, 43214
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19102
      • Wyomissing, Pennsylvania, United States, 19610
    • Tennessee
      • Knoxville, Tennessee, United States, 37920

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo plus Regadenoson
Two placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
Drug: placebo
oral
Drug: regadenoson
IV
Other Names:
  • Lexiscan
  • CVT 3146
Radiation: technetium
IV
Other Names:
  • sestamibi
  • tetrafosmin
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:
  • Lexiscan
  • CVT 3146
Radiation: technetium
IV
Other Names:
  • sestamibi
  • tetrafosmin
Drug: overencapsulated caffeine
oral
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:
  • Lexiscan
  • CVT 3146
Radiation: technetium
IV
Other Names:
  • sestamibi
  • tetrafosmin
Drug: overencapsulated caffeine
oral

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Number of Reversible Defects
Time Frame: 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).
Day 3 and Day 5

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Summed Difference Score (SDS) Across All 17 Segments
Time Frame: 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).
Day 3 and Day 5
Change in Number of Reversible Defects Assessed by Computerized Quantitation
Time Frame: 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).
Day 3 and Day 5
Change in Summed Difference Score Across All 17 Segments Assessed by Computerized Quantitation
Time Frame: 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).
Day 3 and Day 5
Change From Baseline in Heart Rate
Time Frame: 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.
Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min)
Change From Baseline in Systolic Blood Pressure
Time Frame: 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.
Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min)
Change From Baseline in Diastolic Blood Pressure
Time Frame: 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.
Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Astellas Pharma Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Use Central Contact, Astellas Pharma Global Development

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 24, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2009

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3606-CL-3002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

IPD Sharing Time Frame

Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.

IPD Sharing Access Criteria

Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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