Point-of-Care Testing of Coagulation in Patients Treated With Direct Oral Anticoagulants 1 (POCT-DOAC 1)

February 25, 2015 updated by: University Hospital Tuebingen
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

60

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Rivaroxaban
N=20
Apixaban
N=20
Dabigatran
N=20

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Diagnostic accuracy of the CoaguChek POCT to rule out or detect relevant DOAC levels
Time Frame: 24h
24h
Effect/Correlation of DOAC on prothrombin time (PT), activated thromboplastin time (aPTT), anti-Xa activity and Hemoclot assay
Time Frame: 24h
24h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Collaborators

Heart and Diabetes Center North Rhine-Westphalia

Investigators

  • Principal Investigator: Sven Poli, Dr., University Hospital Tuebingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

February 18, 2015

First Submitted That Met QC Criteria

February 24, 2015

First Posted (Estimate)

February 25, 2015

Study Record Updates

Last Update Posted (Estimate)

February 26, 2015

Last Update Submitted That Met QC Criteria

February 25, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • .0 259/2013BO1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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