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High Dose Adenosine for FFR Assessment
NCT02350439Phase 3
Key facts
- Status
- Completed
- Start
- Jan 2015
- Primary completion
- Oct 2015
- Countries
- 1
- Sponsor
- University of Patras
- Modality
- Orthosteric Ligands, Metabolically Activated Prodrugs
- Drugs
- adenosine
- Conditions
- coronary artery disease (CAD)
01
Overview
Phase 3, open-label, single-arm trial of adenosine in coronary artery disease (CAD), sponsored by University of Patras. Primary endpoints: Difference between the maximum and minimum value of Pd / Pa ratio during steady state hyperaemia at 10 minutes and Coefficient of variation of Pd / Pa ratio during steady state hyperemia at 10 minutes. Started Jan 2015; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Adenosine 200μg/kg/min
Patients receiving high dose adenosine after demonstrating variation on standard dose.
03
Who it enrols
Patients aged 18-80 with at least one coronary stenosis ≥50% undergoing FFR who exhibit Pd/Pa variation ≥0.05 during standard adenosine infusion (140μg/kg/min).
04
Endpoints
Primary
Difference between the maximum and minimum value of Pd / Pa ratio during steady state hyperaemia
Coefficient of variation of Pd / Pa ratio during steady state hyperemia
Secondary
FFR value as determined by the software
FFR during steady state hyperemia
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