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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03354273 | An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz (18F) Injection PET MPI in the Detection of Coronary Artery Disease (CAD) | PHASE3 | COMPLETED | 730 | — | — | Jun 5, 2018 | May 5, 2022 | Jul 12, 2023 | 53 | United States, Canada +5 |
Sensitivity was defined as true positives (TP)/(TP+false negatives \[FN\]). TP was participants with abnormal PET MPI and disease positive by truth standard and FN was participants with normal PET MPI and disease positive by truth standard. Specificity defined as true negatives (TN)/(TN+ false positives \[FP\]). TN was participants with normal PET MPI and disease negative by truth standard and FP was participants with abnormal PET MPI and disease negative by truth standard. Truth standard was presence of CAD as evidenced by presence of stenosis of \>=50 percent (%) in \>=1 coronary artery or major branch of a coronary artery as determined by quantitative coronary angiography (QCA) analysis. Participants were considered to have CAD if QCA revealed \>=50% stenosis of \>=1 major coronary artery or major branch. Sensitivity and specificity were calculated for 3 readers and majority rule using each participant judgement (positive or negative) by at least 2 of 3 readers.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Flurpiridaz PET MPI (following off-study SPECT MPI) |
| Name | Type | Description |
|---|---|---|
| PET MPI | DRUG | 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 MPI | DRUG | 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 agents | DRUG | 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. |
Inclusion Criteria: * The participant was a man or woman ≥18 years of age. * The participant had read, signed, and dated an informed consent form (ICF) prior to any study procedures being performed. * At the time of enrolment, the participant had been scheduled via written documentation to undergo ...