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Trial record 34 of 1217 for:    adenosine

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00208299
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : November 26, 2009
Astellas Pharma US, Inc.
Information provided by:
Gilead Sciences

Brief 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Regadenoson Drug: Adenosine Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1231 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: A Phase III, Randomized, Double-Blind Study of Intravenous CVT-3146 Versus Adenoscan® in Patients Undergoing Stress Myocardial Perfusion Imaging
Study Start Date : October 2003
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Drug: Regadenoson
0.4 mg, bolus intravenous injection
Other Names:
  • Lexiscan
  • CVT-3146

Active Comparator: 2
Drug: Adenosine
0.14 mg/kg/min for 6 minutes, intravenous infusion
Other Name: Adenoscan

Primary Outcome Measures :
  1. Non-inferiority of regadenoson to Adenoscan for use in single photon emission computed tomography (SPECT) myocardial perfusion imaging in assessing reversible perfusion defects [ Time Frame: After radiopharmaceutical administration ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00208299

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United States, California
Multiple study locations (see Central Contact); CV Therapeutics, Inc.
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Gilead Sciences
Astellas Pharma US, Inc.

Additional Information:
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Responsible Party: Philip Sager, Vice President, Clinical Research, Gilead Sciences Identifier: NCT00208299    
Other Study ID Numbers: CVT 5131
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: November 26, 2009
Last Verified: November 2009
Keywords provided by Gilead Sciences:
SPECT Myocardial Perfusion Imaging
Reversible Perfusion Defect
Additional relevant MeSH terms:
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Adenosine A2 Receptor Agonists
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action