Plasma Concentration Monitoring of Direct Oral Anticoagulants in Emergency Department Patients: Comparison of Two Laboratory Methods
NCT07917455, Completed, Istituti Clinici Scientifici Maugeri SpA
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Plasma Concentration Monitoring of Direct Oral Anticoagulants in Emergency Department Patients: Comparison of Two Laboratory Methods | ClinicalTrials.gov |
| NCT number | NCT07917455 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Enrollment | 142 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Istituti Clinici Scientifici Maugeri SpA | ClinicalTrials.gov |
| Conditions | Drug Monitoring, Anticoagulants, Factor Xa Inhibitors, Direct Oral Anticoagulants (DOACs), Plasma Concentration | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Agreement between DOAC plasma concentrations measured by chromogenic assay and by HPLC-MS/MS | Day 1 | Intraclass correlation coefficient (ICC, unitless, range 0 to 1) between DOAC plasma concentrations (ng/mL) measured in the same blood sample with a DOAC-specific chromogenic anti-factor IIa/anti-factor Xa assay and with high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS). Higher values indicate better agreement. | ClinicalTrials.gov |
| Secondary | DOAC plasma concentration measured by chromogenic assay | Day 1 | Plasma concentration (ng/mL) of apixaban, dabigatran, edoxaban or rivaroxaban measured with a DOAC-specific chromogenic anti-factor IIa (dabigatran) or anti-factor Xa (apixaban, edoxaban, rivaroxaban) assay. | ClinicalTrials.gov |
| Secondary | DOAC plasma concentration measured by HPLC-MS/MS | Day 1 | Plasma concentration (ng/mL) of apixaban, dabigatran, edoxaban or rivaroxaban measured with a validated high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method. | ClinicalTrials.gov |
| Secondary | Percentage of participants with DOAC plasma concentrations below, within or above the expected range | Day 1 | Percentage of participants whose DOAC plasma concentration, measured by HPLC-MS/MS, falls below, within or above the expected on-treatment range for the specific drug, dose and sampling time (peak or trough). | ClinicalTrials.gov |
| Secondary | Percentage of participants with Emergency Department access for bleeding or thrombosis | Day 1 | Percentage of participants whose reason for Emergency Department access was a coagulation-related problem (major or minor bleeding, or thrombosis), as recorded in the medical record, reported by DOAC plasma concentration category (below, within or above the expected range). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 29433148 | RESULT | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)