Point-of-Care Testing of Coagulation in Patients Treated With Direct Oral Anticoagulants 1
POCT-DOAC 1
1 other identifier
observational
60
0 countries
N/A
Brief Summary
The investigators study aims to test the correlation between the CoaguChek point-of-care testing (POCT) device (Roche, Switzerland) and low plasma levels of all three currently approved direct oral anticoagulants (DOAC; rivaroxaban, apixaban and dabigatran) and to determine the diagnostic accuracy of POCT to rule out or detect relevant levels of DOAC in real-life stroke patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2013
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 18, 2015
CompletedFirst Posted
Study publicly available on registry
February 25, 2015
CompletedFebruary 26, 2015
February 1, 2015
1.3 years
February 18, 2015
February 25, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Effect/Correlation of direct oral anticoagulants (DOAC) on CoaguChek point-of-care testing (POCT) result
DOAC concentrations determined by ultra-performance liquid chromatography-tandem mass spectrometry
24 hours
Secondary Outcomes (2)
Diagnostic accuracy of the CoaguChek POCT to rule out or detect relevant DOAC levels
24h
Effect/Correlation of DOAC on prothrombin time (PT), activated thromboplastin time (aPTT), anti-Xa activity and Hemoclot assay
24h
Study Arms (3)
Rivaroxaban
N=20
Apixaban
N=20
Dabigatran
N=20
Eligibility Criteria
Consecutive stroke patients, who were newly started on oral anticoagulation with rivaroxaban, apixaban or dabigatran for secondary prevention of thromboembolic events.
You may qualify if:
- Stroke patients, who were newly started on oral anticoagulation with rivaroxaban, apixaban or dabigatran for secondary prevention of thromboembolic events
- Age ≥ 18 years
You may not qualify if:
- Vitamin K antagonists or direct oral anticoagulants ≤ 14 days prior to study participation
- Low-molecular weight heparin ≤ 24 hours
- Unfractionated heparin ≤ 12 hours
- Abnormal coagulation values at baseline (Quick \< 70% or activated thromboplastin time (aPTT) \> 40sec.)
- History of coagulopathy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
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.
PMID: 28775134DERIVEDEbner 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.
PMID: 26272385DERIVED
Biospecimen
Whole blood samples and citrated plasma samples
Study Officials
- PRINCIPAL INVESTIGATOR
Sven Poli, Dr.
University Hospital Tuebingen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2015
First Posted
February 25, 2015
Study Start
May 1, 2013
Primary Completion
August 1, 2014
Study Completion
September 1, 2014
Last Updated
February 26, 2015
Record last verified: 2015-02