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

Information source: CV Therapeutics
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Coronary Artery Disease

Intervention: Regadenoson (Drug); Adenosine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: CV Therapeutics

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.

Clinical Details

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

Study design: Diagnostic, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Non-inferiority of regadenoson to Adenoscan for use in single photon emission computed tomography (SPECT) myocardial perfusion imaging in assessing reversible perfusion defects

Secondary outcome:

Safety and tolerability comparison of regadenoson to Adenoscan

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

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Multiple study locations (see Central Contact); CV Therapeutics, Inc., Palo Alto, California 94304, United States
Additional Information

CV Therapeutics, Inc.

Adenoscan®

Starting date: October 2003
Ending date: August 2006
Last updated: April 7, 2008

Page last updated: June 20, 2008

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