CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 46 enrolled
Drug / intervention
adenosine +1 moredrug
Likely dose
adenosine 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/NCT01161121
NCT01161121Phase 1Completed
CompareCT.gov

Utilization of Lexiscan (Regadenoson)in the Cardiac Catheterization Lab to Achieve Maximal Hyperemia for Coronary Physiologic Assessment With Fractional Flow Reserve

St. Louis University·interventional·Posted Jul 13, 2010·Updated Jun 23, 2017

In Brief

A Phase 1 clinical trial evaluating adenosine and regadenoson for Coronary Artery Disease. Completed, enrolled 46 participants across 2 sites.

Detailed Summary

The purpose of this study is to determine if regadenoson is as safe and effective as adenosine when used in the cardiac catheterization lab during measurement of coronary flow reserve and fractional flow reserve. The study hypothesis is the assessment of Fractional Flow Reserve (FFR) in the catheterization lab can be performed with equivalent accuracy when hyperemia is induced with IV Regadenoson compared with IV Adenosine without compromising patient safety.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease
CountriesUnited States
CollaboratorsUniversity of Florida, Astellas Pharma US, Inc.

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 13, 2010
Enrollment StartJul 1, 2010
Primary CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 16.0 years ago

Interventions

adenosinedrug

Measuring FFR and Coronary Flow Reserve after administration of IV adenosine 140 mcg/kg/min for 2 minutes.

regadenosondrug

Measuring FFR and Coronary Flow Reserve after administration of IV regadenoson 0.4 mg over 10 seconds.