Anticoagulation With Direct Oral AnticoagulantsPOCT-DOAC extNCT04679298
Point-of-Care Testing of Coagulation in Patients Treated With Direct Oral Anticoagulants Extended
An observational study of Anticoagulation With Direct Oral Anticoagulants, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The investigators' study aims to test the correlation between CoaguChek point-of-care aPTT testing (Roche, Switzerland) and low plasma levels of all four currently EMA approved direct oral anticoagulants (DOAC; apixaban, dabigatran, edoxaban, and rivaroxaban) and to determine the diagnostic accuracy of POCT to rule… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anticoagulation With Direct Oral Anticoagulants
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 5 Jan 2021to 31 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive stroke patients, who were newly started on oral anticoagulation with apixaban, edoxaban, dabigatran or rivaroxaban for secondary prevention of thromboembolic events
Who may be able to join
- Age ≥ 18 years
- Stroke patients, who were newly started on oral anticoagulation with apixaban, edoxaban, dabigatran or rivaroxaban for secondary prevention of thromboembolic events
- informed consent
Who cannot join
- Vitamin K antagonists ≤ 14 days prior to study participation
- Prior DOAC intake ≤ 72 hours
- Low-molecular weight heparin ≤ 24 hours
- Unfractionated heparin ≤ 12 hours
- Heparinoids (e.g. Fondaparinux) ≤ 72 hours
- Abnormal coagulation values at baseline (Quick < 70% or activated thromboplastin time (aPTT) > 40sec.)
- History of coagulopathy
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Tuebingen
Tübingen, 72070
Sven Poli, MD MSc, +49(0)707129 ext. 83349, sven.poli@uni-tuebingen.de
Joshua Mbroh, MD MSc, +49(0)707129 ext. 80418, joshua.mbroh@med.uni-tuebingen.de
About this study
Official title: Qualitative Coagulation Testing With the CoaguChek(R) Pro II Point-of-Care Test System and aPTT Test Cards in Patients Before and After First Intake of Direct Oral Anticoagulants
The investigators' study aims to test the correlation between CoaguChek point-of-care aPTT testing (Roche, Switzerland) and low plasma levels of all four currently EMA approved direct oral anticoagulants (DOAC; apixaban, dabigatran, edoxaban, and rivaroxaban) and to determine the diagnostic accuracy of POCT to rule out or detect relevant levels of DOAC in real-life stroke patients. Relevant levels are defined as current treatment thresholds according to international guidelines, i.e. 30 and 50 ng/mL.
Read the detailed description
In emergency situations such as an acute stroke or emergency surgery, information on the plasma concentration of DOAC in patients with suspected or known intake of DOAC plays a vital role in making decisions in relation to the administration of i.v thrombolysis therapy- ''Time is brain'' or to consider the administration of an antidote in acute hemorrhagic stroke patients. Moreover, acute stroke patients presenting with aphasia are not in the position to provide information on how regular and when last the anticoagulant was taken.
Although dabigatran for example has lab tests such as the diluted thrombin time (dTT) and the ecarin clotting time (ECT) available, major challenges faced are due to the scarcity of these tests in many hospitals. Also, just like many other lab tests, results could take up to 30-60 minutes (turn-around time due to transport and sample processing) making it inconvenient in critical situations.
In our previous studies, we have been able to show a concentration-dependent effect of Dabigatran on Hemochron® Signature POCT (Werfen, Barcelona, Spain) with all 4 test cards used (PT, aPTT, ACT-LR und ACT+). Dabigatran however failed to show a concentration-dependent effect when tested with the CoaguChek®XS Pro POCT device (Roche, Switzerland) together with the then available prothrombin time (PT) test card. This finding could be attributed to the known low response of dabigatran plasma levels on PT but rather a better response of dabigatran plasma levels on aPTT.
Our study therefore aims to test CoaguChek® Pro II POCT device which is widely available in Europe with the new aPTT test card on all 4 DOAC in order to assess a possible correlation between the aPTT values and the DOAC plasma concentration detected by mass spectrometry, and to evaluate its ability to rule out even very low but clinically relevant DOAC concentrations (e.g., above the currently recommended 30 and 50 ng/mL treatment thresholds). In order to avoid POCT results indicating no relevant DOAC concentrations despite DOAC concentrations being actually elevated, our specificity target is predefined as >95% for detection of elevated DOAC concentrations.
- Keywords
- Direct oral anticoagulants, Acute stroke, Point-of-care testing
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Apixaban | N=20 | |
| Edoxaban | N=20 | |
| Dabigatran | N=20 | |
| Rivaroxaban | N=20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect/Correlation of direct oral anticoagulants (DOAC) on aPTT CoaguChek® Pro II point-of-care testing (POCT) result
DOAC concentrations will be determined by ultra-performance liquid chromatography-tandem mass spectrometry
Measured: 24 hours
Secondary outcomes (2)
Diagnostic accuracy of the CoaguChek® Pro II POCT to rule out or detect relevant DOAC levels
aPTT test card specificity and sensitivity do rule out or detect relevant DOAC plasma concentrations
Measured: 24 hours
Effect/Correlation of DOAC on calibrated DOAC-specific coagulation assays
Response of calibrated anti-thrombin/Xa activity assays to dabigatran/factor Xa inhibitors' plasma levels
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start5 Jan 2021
- Primary completion28 Sep 2022
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anticoagulation With Direct Oral AnticoagulantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Diabetes Center North Rhine-Westphalia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04679298
- Sponsor's protocol ID
- 703/2020BO1
- Acronym
- POCT-DOAC ext
- Status last verified
- Jun 2023
- First submitted
- 16 Dec 2020
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ebner M, Birschmann I, Peter A, Hartig F, Spencer C, Kuhn J, Blumenstock G, Zuern CS, Ziemann U, Poli S. Emergency Coagulation Assessment During Treatment With Direct Oral Anticoagulants: Limitations and Solutions. Stroke. 2017 Sep;48(9):2457-2463. doi: 10.1161/STROKEAHA.117.017981. Epub 2017 Aug 3.
PubMed 28775134Ebner M, Birschmann I, Peter A, Spencer C, Hartig F, Kuhn J, Blumenstock G, Zuern CS, Ziemann U, Poli S. Point-of-care testing for emergency assessment of coagulation in patients treated with direct oral anticoagulants. Crit Care. 2017 Feb 15;21(1):32. doi: 10.1186/s13054-017-1619-z.
PubMed 28196509Ebner M, Peter A, Spencer C, Hartig F, Birschmann I, Kuhn J, Wolf M, Winter N, Russo F, Zuern CS, Blumenstock G, Ziemann U, Poli S. Point-of-Care Testing of Coagulation in Patients Treated With Non-Vitamin K Antagonist Oral Anticoagulants. Stroke. 2015 Oct;46(10):2741-7. doi: 10.1161/STROKEAHA.115.010148. Epub 2015 Aug 13.
PubMed 26272385Hartig F, Birschmann I, Peter A, Horber S, Ebner M, Sonnleitner M, Spencer C, Bombach P, Stefanou MI, Kuhn J, Mengel A, Ziemann U, Poli S. Point-of-care testing of coagulation in patients treated with edoxaban. J Thromb Thrombolysis. 2020 Oct;50(3):632-639. doi: 10.1007/s11239-020-02143-2.
PubMed 32436010
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative Coagulation Testing With the CoaguChek(R) Pro II Point-of-Care Test System and aPTT Test Cards in Patients Before and After First Intake of Direct Oral Anticoagulants
- ClinicalTrials.gov ID
- NCT04679298
- Acronym / sponsor ID
- POCT-DOAC ext / 703/2020BO1
- Keywords
- Direct oral anticoagulants, Acute stroke, Point-of-care testing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Heart and Diabetes Center North Rhine-Westphalia
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 28 Sep 2022 (actual)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 22 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators' study aims to test the correlation between CoaguChek point-of-care aPTT testing (Roche, Switzerland) and low plasma levels of all four currently EMA approved direct oral anticoagulants (DOAC; apixaban, dabigatran, edoxaban, and rivaroxaban) and to determine the diagnostic accuracy of POCT to rule out or detect relevant levels of DOAC in real-life stroke patients. Relevant levels are defined as current treatment thresholds according to international guidelines, i.e. 30 and 50 ng/mL.
Detailed description
In emergency situations such as an acute stroke or emergency surgery, information on the plasma concentration of DOAC in patients with suspected or known intake of DOAC plays a vital role in making decisions in relation to the administration of i.v thrombolysis therapy- ''Time is brain'' or to consider the administration of an antidote in acute hemorrhagic stroke patients. Moreover, acute stroke patients presenting with aphasia are not in the position to provide information on how regular and when last the anticoagulant was taken.
Although dabigatran for example has lab tests such as the diluted thrombin time (dTT) and the ecarin clotting time (ECT) available, major challenges faced are due to the scarcity of these tests in many hospitals. Also, just like many other lab tests, results could take up to 30-60 minutes (turn-around time due to transport and sample processing) making it inconvenient in critical situations.
In our previous studies, we have been able to show a concentration-dependent effect of Dabigatran on Hemochron® Signature POCT (Werfen, Barcelona, Spain) with all 4 test cards used (PT, aPTT, ACT-LR und ACT+). Dabigatran however failed to show a concentration-dependent effect when tested with the CoaguChek®XS Pro POCT device (Roche, Switzerland) together with the then available prothrombin time (PT) test card. This finding could be attributed to the known low response of dabigatran plasma levels on PT but rather a better response of dabigatran plasma levels on aPTT.
Our study therefore aims to test CoaguChek® Pro II POCT device which is widely available in Europe with the new aPTT test card on all 4 DOAC in order to assess a possible correlation between the aPTT values and the DOAC plasma concentration detected by mass spectrometry, and to evaluate its ability to rule out even very low but clinically relevant DOAC concentrations (e.g., above the currently recommended 30 and 50 ng/mL treatment thresholds). In order to avoid POCT results indicating no relevant DOAC concentrations despite DOAC concentrations being actually elevated, our specificity target is predefined as >95% for detection of elevated DOAC concentrations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Apixaban | – | –N=20 |
| Edoxaban | – | –N=20 |
| Dabigatran | – | –N=20 |
| Rivaroxaban | – | –N=20 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive stroke patients, who were newly started on oral anticoagulation with apixaban, edoxaban, dabigatran or rivaroxaban for secondary prevention of thromboembolic events
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Stroke patients, who were newly started on oral anticoagulation with apixaban, edoxaban, dabigatran or rivaroxaban for secondary prevention of thromboembolic events
- informed consent
Key exclusion criteria (7 listed)
- Vitamin K antagonists ≤ 14 days prior to study participation
- Prior DOAC intake ≤ 72 hours
- Low-molecular weight heparin ≤ 24 hours
- Unfractionated heparin ≤ 12 hours
- Heparinoids (e.g. Fondaparinux) ≤ 72 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effect/Correlation of direct oral anticoagulants (DOAC) on aPTT CoaguChek® Pro II point-of-care testing (POCT) result
Time frame: 24 hours
DOAC concentrations will be determined by ultra-performance liquid chromatography-tandem mass spectrometry
2 secondary outcomes
Diagnostic accuracy of the CoaguChek® Pro II POCT to rule out or detect relevant DOAC levels
Time frame: 24 hours
Effect/Correlation of DOAC on calibrated DOAC-specific coagulation assays
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Background: PubMed 28775134Ebner M, Birschmann I, Peter A, Hartig F, Spencer C, Kuhn J, Blumenstock G, Zuern CS, Ziemann U, Poli S. Emergency Coagulation Assessment During Treatment With Direct Oral Anticoagulants: Limitations and Solutions. Stroke. 2017 Sep;48(9):2457-2463. doi: 10.1161/STROKEAHA.117.017981. Epub 2017 Aug 3.
- Background: PubMed 28196509Ebner M, Birschmann I, Peter A, Spencer C, Hartig F, Kuhn J, Blumenstock G, Zuern CS, Ziemann U, Poli S. Point-of-care testing for emergency assessment of coagulation in patients treated with direct oral anticoagulants. Crit Care. 2017 Feb 15;21(1):32. doi: 10.1186/s13054-017-1619-z.
- Background: PubMed 26272385Ebner M, Peter A, Spencer C, Hartig F, Birschmann I, Kuhn J, Wolf M, Winter N, Russo F, Zuern CS, Blumenstock G, Ziemann U, Poli S. Point-of-Care Testing of Coagulation in Patients Treated With Non-Vitamin K Antagonist Oral Anticoagulants. Stroke. 2015 Oct;46(10):2741-7. doi: 10.1161/STROKEAHA.115.010148. Epub 2015 Aug 13.
- Background: PubMed 32436010Hartig F, Birschmann I, Peter A, Horber S, Ebner M, Sonnleitner M, Spencer C, Bombach P, Stefanou MI, Kuhn J, Mengel A, Ziemann U, Poli S. Point-of-care testing of coagulation in patients treated with edoxaban. J Thromb Thrombolysis. 2020 Oct;50(3):632-639. doi: 10.1007/s11239-020-02143-2.
Related trials for Anticoagulation With Direct Oral Anticoagulants
Not yet recruitingPhase 4
Edoxaban Versus Apixaban in Cancer-Associated Venous Thromboembolism
Venous Thromboembolism, Active Cancer
RecruitingPhase 4
Safety and Efficacy of Intravenous Thrombolysis in Patients With Ischemic Stroke and Direct Oral Anticoagulants Intake
Ischemic Stroke
RecruitingPhase 4
Monotherapy With P2Y12 Inhibitors in Patients With Atrial fIbrillation Undergoing Supraflex Stent Implantation
Percutaneous Coronary Intervention (PCI), Atrial Fibrillation (AF)
Recruiting
Effect of Apiban Therapy on AVF Maturation in ESRD Patients
Endstage Renal Disease, Direct Oral Anticoagulants (DOACs)
Enrolling by invitationObservational study
SNAP AF-52: Dose Appropriateness and Adherence to Oral Anticoagulation in Adults ≥65 With Atrial Fibrillation in Primary Care (Ordu, Türkiye)
Medication Adherence, Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anticoagulation With Direct Oral Anticoagulants, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sven Poli, MD MSc (+49(0)707129 ext. 83349, sven.poli@uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect/Correlation of direct oral anticoagulants (DOAC) on aPTT CoaguChek® Pro II point-of-care testing (POCT) result (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04679298, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.