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

NCT ID: NCT00208299

Last Updated: 2009-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1231 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2006-08-31

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Regadenoson

Group Type EXPERIMENTAL

Regadenoson

Intervention Type DRUG

0.4 mg, bolus intravenous injection

2

Adenoscan

Group Type ACTIVE_COMPARATOR

Adenosine

Intervention Type DRUG

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

Interventions

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Regadenoson

0.4 mg, bolus intravenous injection

Intervention Type DRUG

Adenosine

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

Intervention Type DRUG

Other Intervention Names

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Lexiscan CVT-3146 Adenoscan

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma US, Inc.

INDUSTRY

Sponsor Role collaborator

Gilead Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Gilead Sciences

Locations

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

Palo Alto, California, United States

Site Status

Countries

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United States

Related Links

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http://www.adenoscan.com

Adenoscan®

Other Identifiers

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CVT 5131

Identifier Type: -

Identifier Source: org_study_id