NCT04679298

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 22, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

January 5, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

June 29, 2023

Status Verified

June 1, 2023

Enrollment Period

1.7 years

First QC Date

December 16, 2020

Last Update Submit

June 28, 2023

Conditions

Anticoagulation With Direct Oral Anticoagulants

Keywords

Direct oral anticoagulantsAcute strokePoint-of-care testing

Outcome Measures

Primary Outcomes (1)

  • 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

    24 hours

Secondary Outcomes (2)

  • Diagnostic accuracy of the CoaguChek® Pro II POCT to rule out or detect relevant DOAC levels

    24 hours

  • Effect/Correlation of DOAC on calibrated DOAC-specific coagulation assays

    24 hours

Study Arms (4)

Apixaban

N=20

Edoxaban

N=20

Dabigatran

N=20

Rivaroxaban

N=20

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive stroke patients, who were newly started on oral anticoagulation with apixaban, edoxaban, dabigatran or rivaroxaban for secondary prevention of thromboembolic events

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Tuebingen

Tübingen, 72070, Germany

RECRUITING

Related Publications (4)

  • 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: 28775134BACKGROUND

  • Ebner 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.

    PMID: 28196509BACKGROUND

  • Ebner 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: 26272385BACKGROUND

  • Hartig 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.

    PMID: 32436010BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Sven Poli, MD MSc

CONTACT

+49(0)707129sven.poli@uni-tuebingen.de

Joshua Mbroh, MD MSc

CONTACT

+49(0)707129joshua.mbroh@med.uni-tuebingen.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2020

First Posted

December 22, 2020

Study Start

January 5, 2021

Primary Completion

September 28, 2022

Study Completion

August 31, 2023

Last Updated

June 29, 2023

Record last verified: 2023-06

Locations

DE(1)