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

Sponsors and Collaborators:	CV Therapeutics Astellas Pharma US, Inc.
Information provided by:	CV Therapeutics
ClinicalTrials.gov Identifier:	NCT00208312

Purpose

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	Intervention	Phase
Coronary Artery Disease	Drug: Regadenoson Drug: Adenosine	Phase III

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Adenosine CVT 3146

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase III, Randomized, Double-Blind Study of Intravenous CVT-3146 Versus Adenoscan® in Patients Undergoing Stress Myocardial Perfusion Imaging

Further study details as provided by CV Therapeutics:

Primary Outcome Measures:

Non-inferiority of regadenoson to Adenoscan for use in SPECT myocardial perfusion imaging in assessing reversible perfusion defects [ Time Frame: After radiopharmaceutical administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability comparison of regadenoson to Adenoscan [ Time Frame: Up to two weeks ] [ Designated as safety issue: Yes ]
Additional comparisons of images obtained with regadenoson to those obtained with Adenoscan [ Time Frame: After radiopharmaceutical administration ] [ Designated as safety issue: No ]

Enrollment:	787
Study Start Date:	April 2004
Study Completion Date:	June 2005
Primary Completion Date:	June 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Regadenoson	Drug: Regadenoson 0.4 mg, bolus intravenous injection
2: Active Comparator Adenoscan	Drug: Adenosine 0.14 mg/kg/min for 6 minutes, intravenous infusion

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00208312

Locations

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

Sponsors and Collaborators

CV Therapeutics

Astellas Pharma US, Inc.

More Information

CV Therapeutics, Inc. This link exits the ClinicalTrials.gov site

Adenoscan® This link exits the ClinicalTrials.gov site

Publications of Results:

Iskandrian AE, Bateman TM, Belardinelli L, Blackburn B, Cerqueira MD, Hendel RC, Lieu H, Mahmarian JJ, Olmsted A, Underwood SR, Vitola J, Wang W; ADVANCE MPI Investigators. Adenosine versus regadenoson comparative evaluation in myocardial perfusion imaging: results of the ADVANCE phase 3 multicenter international trial. J Nucl Cardiol. 2007 Sep-Oct;14(5):645-58.

Responsible Party:	CV Therapeutics ( Carol D. Karp, Senior Vice President, Regulatory Affairs, Quality and Drug Safety )
Study ID Numbers:	CVT 5132
Study First Received:	September 13, 2005
Last Updated:	April 7, 2008
ClinicalTrials.gov Identifier:	NCT00208312
Health Authority:	United States: Food and Drug Administration

Keywords provided by CV Therapeutics:

Lexiscan
Regadenoson
Adenoscan®

Adenosine
SPECT Myocardial Perfusion Imaging
Reversible Perfusion Defect

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Stress
Arteriosclerosis
Ischemia
Adenosine
Coronary Artery Disease

Additional relevant MeSH terms:

Vasodilator Agents
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Cardiovascular Diseases
Cardiovascular Agents

Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009