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

On Track

Trial Health Score

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

Enrollment

1,231

participants targeted

Target at P75+ for phase_3 coronary-artery-disease

Timeline

Completed

Started Oct 2003

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

2.8 years study duration

Study Start

First participant enrolled

October 1, 2003

Completed

2 years 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

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed

Last Updated

November 26, 2009

Status Verified

November 1, 2009

Enrollment Period

2.8 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 single photon emission computed tomography (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

AdenosineDRUG

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

Also known as: Adenoscan

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

Gilead Scienceslead
Astellas Pharma US, Inc.collaborator

Study Sites (1)

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

Palo Alto, California, 94304, United States

Location

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

October 1, 2003

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

November 26, 2009

Record last verified: 2009-11

Locations

US(1)

ADVANCE MPI 1: Study of Regadenoson Versus Adenoscan® in Patients Undergoing Myocardial Perfusion Imaging (MPI)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Design

Study Record Dates

Locations