Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01347710 | A Phase 3 Multi-center Study to Assess PET Imaging of Flurpiridaz F 18 Injection in Patients With CAD. | PHASE3 | COMPLETED | 795 | — | — | Jun 1, 2011 | Sep 1, 2013 | Nov 24, 2020 | 81 | United States, Canada +2 |
Diagnostic efficacy of one day rest and stress flurpiridaz F 18 PET MPI sensitivity versus SPECT MPI sensitivity in the detection of coronary artery disease (CAD) by majority rule using invasive coronary angiography as the truth standard,
Diagnostic efficacy of flurpiridaz PET MPI specificity versus SPECT MPI specificity by majority rule in the detection of CAD using invasive coronary angiography as the truth standard
| Arm | Type | Description |
|---|---|---|
| Flurpiridaz F18 | EXPERIMENTAL | Open-label study of a single dose of Flurpiridaz F18 injection for PET MPI compared to a single dose of 99mTc sestamibi or tetrofosmin for SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization |
| Name | Type | Description |
|---|---|---|
| Flurpiridaz F18 | DRUG | Injection of Flurpiridaz F18 for the purposes of PET myocardial profusion imaging (MPI) analysis |
| 99mTechnicium (sestamibi or tetrofosmin) | DRUG | Injection of 99mTc sestamibi or tetrofosmin for the purposes of SPECT MPI analysis |
Inclusion Criteria: Invasive Coronary Angiography. Men or Women age 18 or older - see protocol for additional details. Exclusion Criteria: Women who are pregnant, lactating, or of child bearing potential who are not practicing birth control. Unstable cardiac status. History of coronary artery by...