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OpenTrials
Completed

NCT Number: NCT02371044

Point-of-Care Testing of Coagulation in Patients Treated With Direct Oral Anticoagulants 1

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.

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Key information

Conditions

Anticoagulation With Direct Oral Anticoagulants

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Stroke patients, who were newly started on oral anticoagulation with rivaroxaban, apixaban or dabigatran for secondary prevention of thromboembolic events
  • Age ≥ 18 years

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Effect/Correlation of direct oral anticoagulants (DOAC) on CoaguChek point-of-care testing (POCT) result

    Time frame: 24 hours

    DOAC concentrations determined by ultra-performance liquid chromatography-tandem mass spectrometry

Secondary outcomes

  1. Diagnostic accuracy of the CoaguChek POCT to rule out or detect relevant DOAC levels

    Time frame: 24h

  2. Effect/Correlation of DOAC on prothrombin time (PT), activated thromboplastin time (aPTT), anti-Xa activity and Hemoclot assay

    Time frame: 24h

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Collaborators

  • Heart and Diabetes Center North Rhine-Westphalia

Registry information

Acronym: POCT-DOAC 1

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 25, 2015
Registry last updated
Feb 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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