Anticoagulation With NOAC Clinical Trial
— SPOCT-DOAC 1Official title:
Specific Point-of-Care Testing of Coagulation in Patients Treated With Direct Oral Anticoagulants Part 1
| NCT number | NCT02825394 |
| Other study ID # | 270/2015BO1 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | October 13, 2016 |
| Est. completion date | July 2021 |
The investigators study aims to test the correlation between the Cascade Abrazo point-of-care testing (POCT) device (Helena Laboratories, USA) and plasma levels of apixaban, dabigatran, edoxaban and rivaroxaban, and to determine the diagnostic accuracy of POCT to rule out or detect relevant levels of direct oral anticoagulants (DOAC) in real-life patients.
| Status | Recruiting |
| Enrollment | 160 |
| Est. completion date | July 2021 |
| Est. primary completion date | March 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Part A only: planned initiation of treatment with apixaban, dabigatran, edoxaban or rivaroxaban - Part B only: ongoing treatment with apixaban, dabigatran, edoxaban or rivaroxaban - Age = 18 years - Written informed consent by patient Exclusion Criteria: - Part A only: intake of vitamin K antagonists or direct oral anticoagulants (DOAC) = 14 days prior to study participation - Part B only: intake of vitamin K antagonists or different DOAC = 14 days prior to study participation - Intake of unfractionated heparin = 12 hours, low-molecular-weight heparin = 24h, heparinoids (e.g. fondaparinux) = 72h, or direct thrombin inhibitors other than dabigatran = 72h prior to study participation - Part A only: abnormal routine coagulation test values at baseline (defined by INR > 1.2, Quick < 70% or aPTT > 40 sec) - History of coagulopathy |
| Country | Name | City | State |
|---|---|---|---|
| Germany | University Hospital Tuebingen | Tuebingen |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital Tuebingen | Heart and Diabetes Center North Rhine-Westphalia |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Correlation of direct oral anticoagulant (DOAC) plasma concentration with Cascade Abrazo point-of-care testing (POCT) result | DOAC concentrations determined by ultra-performance liquid chromatography-tandem mass spectrometry | 24 hours | |
| Secondary | Diagnostic accuracy (sensitivity and specificity) of the Cascade Abrazo POCT to rule out or detect relevant DOAC plasma levels | 24 hours | ||
| Secondary | Correlation of DOAC plasma concentrations with laboratory-based prothrombin time (PT) assay | 24 hours | ||
| Secondary | Correlation of DOAC plasma concentrations with laboratory-based activated thromboplastin time (aPTT) assay | 24 hours | ||
| Secondary | Correlation of DOAC plasma concentrations with laboratory-based thrombin time (TT) assay | 24 hours | ||
| Secondary | Correlation of DOAC plasma concentrations with laboratory-based diluted thrombin time (dTT) assay | 24 hours | ||
| Secondary | Correlation of DOAC plasma concentrations with laboratory-based ecarin clotting time (ECT) assay | 24 hours | ||
| Secondary | Correlation of DOAC plasma concentrations with laboratory-based anti-Xa activity assay | 24 hours | ||
| Secondary | Correlation of edoxaban plasma concentrations with CoaguChek point-of-care prothrombin time (PT) assay | 24 hours | ||
| Secondary | Correlation of edoxaban plasma concentrations with Hemochron Signature point-of-care prothrombin time (PT) assay | 24 hours | ||
| Secondary | Correlation of edoxaban plasma concentrations with Hemochron Signature point-of-care activated thromboplastin time (aPTT) assay | 24 hours | ||
| Secondary | Correlation of edoxaban plasma concentrations with Hemochron Signature point-of-care activated clotting time plus (ACT+) assay | 24 hours | ||
| Secondary | Correlation of edoxaban plasma concentrations with Hemochron Signature point-of-care activated clotting time low-range (ACT-LR) assay | 24 hours |