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Coronary Artery Disease (CAD)Phase 3NCT00826280

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

A Phase 3 study testing regadenoson, overencapsulated caffeine and technetium in people with Coronary Artery Disease (CAD), run by Astellas Pharma Inc at 25 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease (CAD)
What is being tested?
regadenoson, overencapsulated caffeine and technetium
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
347 participants
Where
25 sitesUnited States
Study dates
24 Mar 2009to 15 Jul 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

United States25 sites

  • Study site

    Albany, New York, 12205

  • Study site

    Auburn, Maine, 04210

  • Study site

    Aurora, Illinois, 60504

  • Study site

    Birmingham, Alabama, 35294

  • Study site

    Columbus, Ohio, 43214

  • Study site

    Detroit, Michigan, 48202

  • Study site

    Hartford, Connecticut, 06102-5037

  • Study site

    Huntsville, Alabama, 35801

  • Study site

    Jacksonville, Florida, 32216

  • Study site

    Kansas City, Missouri, 64111

  • Study site

    Knoxville, Tennessee, 37920

  • Study site

    La Mesa, California, 91942

  • Study site

    Miami, Florida, 33173

  • Study site

    Mission Viejo, California, 92691

  • Study site

    Newark, Delaware, 19173

  • Study site

    Overland Park, Kansas, 66209

  • Study site

    Philadelphia, Pennsylvania, 19102

  • Study site

    Pittsfield, Massachusetts, 01201

  • Study site

    Rochester, New York, 14642-8679

  • Study site

    Roseville, California, 95661

  • Study site

    Sacramento, California, 95819

  • Study site

    Santa Rosa, California, 95405

  • Study site

    Tamarac, Florida, 33321

  • Study site

    Wyomissing, Pennsylvania, 19610

  • Study site

    Ypsilanti, Michigan, 48197

Other trials in United States

About this study

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

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

Read the 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.

Being tested
regadenoson, overencapsulated caffeine, technetium, placebo
Keywords
pharmacologic stress, ischemia, coronary artery disease (CAD)
Medical subject headings
Coronary Artery Disease, Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • regadenosonDrug

    Also called Lexiscan, CVT 3146

    IV

  • overencapsulated caffeineDrug

    oral

  • technetiumRadiation

    Also called sestamibi, tetrafosmin

    IV

  • placeboDrug

    oral

Study groups in NCT00826280
Study groupRoleWhat they receive
Placebo plus RegadenosonPlacebo comparatorTwo placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
Receives: Drug: regadenoson; Radiation: technetium; Drug: placebo
Caffeine 200 mg plus RegadenosonExperimentalOne 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
Receives: Drug: regadenoson; Drug: overencapsulated caffeine; Radiation: technetium
Caffeine 400 mg plus RegadenosonExperimentalTwo 200 mg Caffeine capsules plus 0.4 mg regadenoson per 5mL intravenous bolus injection
Receives: Drug: regadenoson; Drug: overencapsulated caffeine; Radiation: technetium

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Day 3 and Day 5

Secondary outcomes (6)

  1. 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).

    Measured: Day 3 and Day 5

  2. 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).

    Measured: Day 3 and Day 5

  3. 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).

    Measured: Day 3 and Day 5

  4. 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.

    Measured: Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min)

  5. 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.

    Measured: Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min)

  6. 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.

    Measured: Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2009 (estimated)
  2. Study start24 Mar 2009
  3. Primary completion15 Jul 2010
  4. Study completion15 Jul 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
347 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00826280
Sponsor's protocol ID
3606-CL-3002
Status last verified
Nov 2024
First submitted
21 Jan 2009
Last updated
3 Dec 2024
Data monitoring committee
No
Individual data sharing
Yes: 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/.

Publications

  • Tejani FH, Thompson RC, Iskandrian AE, McNutt BE, Franks B. Effect of caffeine on SPECT myocardial perfusion imaging during regadenoson pharmacologic stress: rationale and design of a prospective, randomized, multicenter study. J Nucl Cardiol. 2011 Feb;18(1):73-81. doi: 10.1007/s12350-010-9311-6. Epub 2010 Nov 17.

    PubMed 21082298

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing regadenoson, overencapsulated caffeine and technetium in people with Coronary Artery Disease (CAD), run by Astellas Pharma Inc at 25 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Number of Reversible Defects (time frame: Day 3 and Day 5). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00826280, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.

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