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

Phase

Condition

Coronary Artery Disease

Chest Pain

Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT00208299

CVT 5131

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Referred for a clinically indicated pharmacological stress SPECT myocardial perfusionimaging study

Exclusion

Exclusion Criteria:

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

Study Design

October 01, 2003

August 31, 2006

Study Description

ADVANCE MPI 1 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:

to compare the pharmacological stress SPECT images obtained with regadenoson to those obtained with Adenoscan, and
to compare the safety and tolerability of the two stress agents.

Connect with a study center

Multiple study locations (see Central Contact); CV Therapeutics, Inc.
Palo Alto, California 94304
United States
Site Not Available

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