ADVANCE MPI 2: Study of Regadenoson Versus Adenoscan® in Patients Undergoing Myocardial Perfusion Imaging (MPI)

A Phase III, Randomized, Double-Blind Study of Intravenous CVT-3146 Versus Adenoscan® in Patients Undergoing Stress Myocardial Perfusion Imaging

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00208312

Enrollment

787

Registered

2005-09-21

Start date

2004-04-30

Completion date

2005-06-30

Last updated

2009-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Lexiscan, Regadenoson, Adenoscan®, Adenosine, SPECT Myocardial Perfusion Imaging, Reversible Perfusion Defect

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.

Detailed description

ADVANCE MPI 2 is a multi-national, double-blind, randomized, active-controlled, parallel group clinical trial to evaluate the safety and efficacy of regadenoson in SPECT MPI compared to that of the approved pharmacological stress agent, Adenoscan. Patients referred for a clinically indicated pharmacological stress MPI study will be eligible for enrollment. The trial is designed: (1) to compare the pharmacological stress SPECT images obtained with regadenoson to those obtained with Adenoscan, and (2) to compare the safety and tolerability of the two stress agents.

Interventions

DRUGRegadenoson

0.4 mg, bolus intravenous injection

DRUGAdenosine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
Non-inferiority of regadenoson to Adenoscan for use in SPECT myocardial perfusion imaging in assessing reversible perfusion defects	After radiopharmaceutical administration

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026