Patient satisfaction of direct oral anticoagulant treatment and the possible need to monitor patients on direct oral anticoagulan treatment on anticoagulation levels in their blood

The Need for Titration or Monitoring of Direct Oral Anticoagulant Treatment: The MONDOAC and KIDOAC study - MONDOAC AND KIDOAC

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003677-33-NL

Enrollment

150

Registered

2018-01-18

Start date

2018-02-02

Completion date

Unknown

Last updated

2018-03-05

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

Conditions

patients who are diagnosed with atrial fibrillation or venous thrombosis

Interventions

Trade Name: Pradaxa Pharmaceutical Form: Capsule Trade Name: xarelto Pharmaceutical Form: Tablet Trade Name: eliquis Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with (initial or recurrent) confirmed symptomatic deep vein thrombosis, pulmonary embolism or atrial fibrillation who are allowed to switch (or switched =65 years) yes F.1.3.1 Number of subjects for this age range 75

Exclusion criteria

Exclusion criteria: 1. Life expectancy less than 6 months 2. Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the person’s successful participation in the study as required by protocol (including alcohol or drug abuse) 3. Previous participation in the study

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the within and between variability of pharmacokinetic (PK) profiles in patients treated with DOACs in daily practice (KIDOAC study).;Secondary Objective: To study DOAC treatment adherence, persistence and satisfaction patterns in patients who receive a direct oral anticoagulant (DOAC);Primary end point(s): PT aPTT Hemoclot (to determine dabigatran concentrations) anti-Xa levels (rivaroxaban and apixaban concentrations);Timepoint(s) of evaluation of this end point: 10-14 days 28-31 days 60 days	—

Measure

Time frame

Main Objective: To determine the within and between variability of pharmacokinetic (PK) profiles in patients treated with DOACs in daily practice (KIDOAC study).;Secondary Objective: To study DOAC treatment adherence, persistence and satisfaction patterns in patients who receive a direct oral anticoagulant (DOAC);Primary end point(s): PT aPTT Hemoclot (to determine dabigatran concentrations) anti-Xa levels (rivaroxaban and apixaban concentrations);Timepoint(s) of evaluation of this end point: 10-14 days 28-31 days 60 days

—

Secondary

Measure	Time frame
Secondary end point(s): none;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Netherlands

Contacts

Public ContactStudy Coordinator

Leiden University Medical Center

w.m.lijfering@lumc.nl0031715261384

Outcome results

None listed

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