CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 730 enrolled
Drug / intervention
PET MPI +2 moredrug
Likely dose
Not stated in 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/NCT03354273
NCT03354273Phase 3Completed
CompareCT.gov

A Phase 3, Open-Label, Multicentre Study of Flurpiridaz (18F) Injection for Positron Emission Tomography (PET) Imaging for Assessment of Myocardial Perfusion in Patients Referred for Invasive Coronary Angiography Because of Suspected Coronary Artery Disease

GE Healthcare·interventional·Posted Nov 27, 2017·Updated Jul 12, 2023

In Brief

A Phase 3 clinical trial evaluating PET MPI, SPECT MPI, and 1 other intervention for Coronary Artery Disease (CAD). Completed, enrolled 730 participants across 53 sites in 7 countries.

Detailed Summary

This is a Phase 3, prospective, open-label, international, multicentre study of Flurpiridaz (18F) Injection for PET MPI in patients referred for ICA because of suspected CAD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease (CAD)
CountriesCanada, Finland, France, Germany, Netherlands, Switzerland, United States
CollaboratorsPharmaceutical Product Development, (PPD) LLC

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedNov 27, 2017
Enrollment StartJun 5, 2018
Primary CompletionMay 5, 2022
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 8.6 years ago

Interventions

PET MPIdrug

Flurpiridaz (18F) Injection. All participants received 2 IV boluses of Flurpiridaz (18F) Injection in a large peripheral vein: 1 at rest and 1 during stress. The dosages of Flurpiridaz (18F) Injection administered at rest and during stress conditions did not exceed a total of 14 mCi (520 MBq) for an individual participant.

SPECT MPIdrug

SPECT imaging was used 99mTc-based myocardial tracers. SPECT agents utilised for the purposes of this clinical study was administered as per American Society of Nuclear Cardiology or European Association of Cardiovascular Imaging standards, where applicable. All participants undergone SPECT MPI.

Pharmacological stress agentsdrug

Pharmacologic stress agents were restricted to the following 3 agents, as permitted by local marketing authorisations and availability: adenosine, dipyridamole, and regadenoson. Administration was through an IV line.