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

Information source: Gilead Sciences
ClinicalTrials.gov processed this data on August 23, 2015
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: Gilead Sciences


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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Primary outcome: Non-inferiority of regadenoson to Adenoscan for use in 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 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.


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


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


Starting date: April 2004
Last updated: November 24, 2009

Page last updated: August 23, 2015

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