The effect of body weight on trough concentrations of DOACs in patients.

Completed

• Conditions: TDM; trough concentration/ concentration prior to next dose

• Registration Number: NL-OMON46689
• Lead Sponsor: HagaZiekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-01-23
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 167

Inclusion Criteria

- Male or female * 18 years
- Treated with a DOAC (rivaroxaban, dabigatran, apixaban, edoxaban) in a therapeutic or prophylactic dosage for at least five days
- eGFR > 50 ml/min
- Is not mentally disabled
- Good understanding of the Dutch language
- Written informed consent

Exclusion Criteria

- Collected blood sample is not a trough concentration
- Relevant co-medication (table 1 of study-protocol)

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is body weight and the primary endpoint is the DOAC<br /><br>trough concentration. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoints will be<br /><br>- The trough anti-FXa activity (apixaban, rivaroxaban and edoxaban)<br /><br>- The trough anti-FIIa activity (dabigatran)</p><br>