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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00208299
• Other study ID #: CVT 5131
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: November 24, 2009
• Start date: October 2003
• Est. completion date: August 2006

Study information

• Verified date: November 2009
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1231
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Regadenoson
0.4 mg, bolus intravenous injection
• Adenosine
0.14 mg/kg/min for 6 minutes, intravenous infusion

Locations

Country	Name	City	State
United States	Multiple study locations (see Central Contact); CV Therapeutics, Inc.	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Gilead Sciences	Astellas Pharma US, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-inferiority of regadenoson to Adenoscan for use in single photon emission computed tomography (SPECT) myocardial perfusion imaging in assessing reversible perfusion defects		After radiopharmaceutical administration	No
Secondary	Safety and tolerability comparison of regadenoson to Adenoscan		Up to two weeks	Yes
Secondary	Additional comparisons of images obtained with regadenoson to those obtained with Adenoscan		After radiopharmaceutical administration	No

External Links

•   Adenoscan®