CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 48 enrolled
Drug / intervention
FFR Measurement with IV Adenoscan® then with Regadenosondrug
Likely dose
FFR Measurement with IV Adenoscan® then with Regadenoson 140 mcg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01482169
NCT01482169N/ACompleted
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Efficacy of Intravenous Regadenoson Versus Intravenous Adenoscan® for Fractional Flow Reserve Measurements

Ochsner Health System·interventional·Posted Nov 30, 2011·Updated May 11, 2018

In Brief

A clinical study evaluating FFR Measurement with IV Adenoscan® then with Regadenoson for Coronary Artery Disease. Completed, enrolled 48 participants across 1 site.

Detailed Summary

The purpose of this study is to demonstrate that intravenous regadenoson is equivalent to intravenous Adenoscan® for the physiological assessment of intermediate coronary lesions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease
CountriesUnited States
CollaboratorsAstellas Pharma Global Development, Inc.

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 30, 2011
Enrollment StartMar 1, 2012
Primary CompletionMay 1, 2014
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 14.6 years ago

Interventions

FFR Measurement with IV Adenoscan® then with Regadenosondrug

Testing will be completed during a Left Heart Catheterization (LHC). The first 48 eligible patients enrolled will receive an initial infusion of IV Adenoscan® through a peripheral vein at 140 mcg/kg/min. FFR measurements will be obtained utilizing a coronary pressure guide wire once peak hyperemia has been achieved. It takes about 84 seconds to reach peak hyperemia with Adenoscan®. Subsequently, these subjects will receive a dose of regadenoson at 0.4 mg through the same peripheral access site. FFR measurements will be obtained once peak hyperemia is achieved, which takes less than 30 seconds with regadenoson. Patients who react to either medication will be supported conservatively under close scrutiny.