NCT00208312

Brief Summary

Adenoscan® (adenosine) is an approved pharmacological stress agent indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately. The investigational drug, regadenoson (CVT-3146) is a selective A2A adenosine receptor agonist, the receptor responsible for coronary vasodilation, and is being studied for potential use as a pharmacologic stress agent in myocardial perfusion imaging (MPI) studies. This study will compare the safety and efficacy of regadenoson to that of Adenoscan in detecting reversible myocardial perfusion defects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
787

participants targeted

Target at P75+ for phase_3 coronary-artery-disease

Timeline
Completed

Started Apr 2004

Shorter than P25 for phase_3 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

November 26, 2009

Status Verified

November 1, 2009

Enrollment Period

1.2 years

First QC Date

September 13, 2005

Last Update Submit

November 24, 2009

Conditions

Coronary Artery Disease

Keywords

LexiscanRegadenosonAdenoscan®AdenosineSPECT Myocardial Perfusion ImagingReversible Perfusion Defect

Outcome Measures

Primary Outcomes (1)

  • Non-inferiority of regadenoson to Adenoscan for use in SPECT myocardial perfusion imaging in assessing reversible perfusion defects

    After radiopharmaceutical administration

Secondary Outcomes (2)

  • Safety and tolerability comparison of regadenoson to Adenoscan

    Up to two weeks

  • Additional comparisons of images obtained with regadenoson to those obtained with Adenoscan

    After radiopharmaceutical administration

Study Arms (2)

1

EXPERIMENTAL

Regadenoson

Drug: Regadenoson

2

ACTIVE COMPARATOR

Adenoscan

Drug: Adenosine

Interventions

RegadenosonDRUG

0.4 mg, bolus intravenous injection

Also known as: Lexiscan, CVT-3146
1
AdenosineDRUG

0.14 mg/kg/min for 6 minutes, intravenous infusion

Also known as: Adenoscan
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Referred for a clinically indicated pharmacological stress SPECT myocardial perfusion imaging study

You may not qualify if:

  • Any condition precluding the safe administration of Adenoscan for a SPECT myocardial perfusion imaging study
  • Pregnant or breast-feeding, or (if pre-menopausal), not practicing acceptable method of birth control

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Multiple study locations (see Central Contact); CV Therapeutics, Inc.

Palo Alto, California, 94304, United States

Location

Related Publications (1)

  • Iskandrian AE, Bateman TM, Belardinelli L, Blackburn B, Cerqueira MD, Hendel RC, Lieu H, Mahmarian JJ, Olmsted A, Underwood SR, Vitola J, Wang W; ADVANCE MPI Investigators. Adenosine versus regadenoson comparative evaluation in myocardial perfusion imaging: results of the ADVANCE phase 3 multicenter international trial. J Nucl Cardiol. 2007 Sep-Oct;14(5):645-58. doi: 10.1016/j.nuclcard.2007.06.114.

    PMID: 17826318RESULT

Related Links

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

regadenosonAdenosine

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Purine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

April 1, 2004

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

November 26, 2009

Record last verified: 2009-11

Locations

US(1)