Study of the Safety and Efficacy of Apadenoson for Detection of Myocardial Perfusion Defects Using SPECT MPI
(ASPECT2 Trial)

Recruiting in Palo Alto (17 mi)

+85 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Forest Laboratories

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to see whether apadenoson is as effective as adenosine when used as a pharmacological stress agent in myocardial SPECT-imaging (SPECT-MPI)to detect defects in the supply of blood to the heart muscle (myocardial perfusion defects). The study will also look at whether apadenoson is better tolerated than adenosine when used in SPECT-MPI.

Research Team

David B Bharucha, MD, PhD, FACC

Principal Investigator

Forest Laboratories

Eligibility Criteria

Inclusion Criteria

Referred for a clinically indicated rest/pharmacologic stress SPECT-MPI test

High pretest probability (90% or greater) of CAD based on the ACC/AHA guidelines for relative risk, or past medical h/o CAD

Treatment Details

Interventions

Adenosine SPECT-MPI (Pharmacological Stress Agent)
Apadenoson SPECT-MPI (Pharmacological Stress Agent)

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: ApadenosonExperimental Treatment2 Interventions

In period 1, subjects will receive a clinically-indicated rest/stress gated SPECT-MPI with adenosine. In period 2, subjects will receive a rest/stress gated SPECT-MPI with apadenoson

Group II: AdenosineActive Control2 Interventions

In period 1, subjects will receive a clinically-indicated rest/stress gated SPECT-MPI with adenosine. In period 2, subjects will receive a rest/stress gated SPECT-MPI with the active comparator: adenosine.