The effect of body weight on the medicine concentrations of dabigatran, edoxaban, apixaban and rivaroxaban in blood.

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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003569-91-NL

Enrollment

160

Registered

2017-09-21

Start date

2017-12-08

Completion date

Unknown

Last updated

2018-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

No medical condition will be investigated. This study will only investigate the effect of body weight on through concentrations of direct oral anticoagulants (DOACs)

Interventions

Trade Name: Eliquis Product Name: Apixaban Product Code: EU/1/11/691/001 Pharmaceutical Form: Coated tablet Trade Name: Pradaxa Product Name: Dabigatran Product Code: EU/1/08/442/001 Pharmaceutical F

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Male or female = 18 years - Treated with a DOAC (rivaroxaban, dabigatran, apixaban, edoxaban) in a therapeutic or prophylactic dosage for at least three days - Is not mentally disabled - Good understanding of the Dutch language - Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: - Collected blood sample is not a trough concentration

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effect of body weight on the trough concentrations of DOACs in patients. ;Secondary Objective: - To investigate the effect of body weight on anti-Factor Xa (FXa) activity for apixaban, rivaroxaban and edoxaban. - To investigate the effect of body weight on anti-Factor IIa (FIIa) activity for dabigatran. ;Primary end point(s): The DOAC trough concentration;Timepoint(s) of evaluation of this end point: One year after initial start of the BC_DOAC study	—

Measure

Time frame

Main Objective: To investigate the effect of body weight on the trough concentrations of DOACs in patients. ;Secondary Objective: - To investigate the effect of body weight on anti-Factor Xa (FXa) activity for apixaban, rivaroxaban and edoxaban. - To investigate the effect of body weight on anti-Factor IIa (FIIa) activity for dabigatran. ;Primary end point(s): The DOAC trough concentration;Timepoint(s) of evaluation of this end point: One year after initial start of the BC_DOAC study

—

Secondary

Measure	Time frame
Secondary end point(s): - The anti-Factor Xa (FXa) activity for apixaban, rivaroxaban and edoxaban. - The anti-Factor IIa (FIIa) activity for dabigatran. ;Timepoint(s) of evaluation of this end point: One year after initial start of the BC_DOAC study	—

Countries

Netherlands

Contacts

Public ContactHospital

Hagaziekenhuis

0031702100000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026