drugset / Trial / NCT03354273
An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz (18F) Injection PET MPI in the Detection of Coronary Artery Disease (CAD)
NaSingle-groupOpen-labelDiagnostic
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.
Timeline
- Start
- 2018-06-05
- Primary completion
- 2022-05-05
- Completion
- 2022-05-05
Publications
- Patel KK, Maddahi J, Agostini D, Bax JJ, Beanlands RSB, Berman D, Dorbala S, Heller GV, Knuuti JM, Pelletier-Galarneau M, Tamaki N, Thompson D, Somer EJ, Udelson JE, Bateman TM. Improved assessment of coronary artery disease in obese Patients with flurpiridaz-18F positron emission tomography myocardial perfusion imaging: A prespecified subgroup analysis of the AURORA phase 3 study. J Nucl Cardiol. 2026 May 12:102741. doi: 10.1016/j.nuclcard.2026.102741. Online ahead of print.
- Maddahi J, Agostini D, Bateman TM, Bax JJ, Beanlands RSB, Berman DS, Dorbala S, Garcia EV, Feldman J, Heller GV, Knuuti JM, Martinez-Clark P, Pelletier-Galarneau M, Shepple B, Tamaki N, Tranquart F, Udelson JE. Flurpiridaz F-18 PET Myocardial Perfusion Imaging in Patients With Suspected Coronary Artery Disease. J Am Coll Cardiol. 2023 Oct 17;82(16):1598-1610. doi: 10.1016/j.jacc.2023.08.016.
- Bourque JM, Hanson CA, Agostini D, Bateman TM, Bax JJ, Beanlands RSB, Berman DS, Garcia EV, Heller GV, Knuuti J, Tamaki N, Udelson JE, Maddahi J. Assessing myocardial perfusion in suspected coronary artery disease: rationale and design of the second phase 3, open-label multi-center study of flurpiridaz (F-18) injection for positron emission tomography (PET) imaging. J Nucl Cardiol. 2021 Jun;28(3):1105-1116. doi: 10.1007/s12350-021-02527-8. Epub 2021 Jan 31.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Flurpiridaz | Diagnostic / imaging agent | 520 mbq | Intravenous |
| Background | Adenosine | Small molecule | — | Intravenous |
| Background | Dipyridamole | Other / unclassified | — | Intravenous |
| Background | Regadenoson | Diagnostic / imaging agent | — | Intravenous |