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NCT Number: NCT00208312

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Regadenoson

Drug

0.4 mg, bolus intravenous injection

Other names: Lexiscan, CVT-3146

Adenosine

Drug

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

Other names: Adenoscan

Primary outcomes

  1. Non-inferiority of regadenoson to Adenoscan for use in SPECT myocardial perfusion imaging in assessing reversible perfusion defects

    Time frame: After radiopharmaceutical administration

Secondary outcomes

  1. Safety and tolerability comparison of regadenoson to Adenoscan

    Time frame: Up to two weeks

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

    Time frame: After radiopharmaceutical administration

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Collaborators

  • Astellas Pharma US, Inc.

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Sep 21, 2005
Registry last updated
Nov 26, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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