Laboratory measurement of direct oral anticoagulants on patients with atrial fibrillation.

Laboratory measurement of direct oral anticoagulants on patients with atrial fibrillation - Laboratory measurement of anticoagulants dabigatran, rivaroxaban, apixaban and edoxaban.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002105-18-FI

Enrollment

200

Registered

2016-10-19

Start date

2017-05-04

Completion date

Unknown

Last updated

2024-10-28

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

Conditions

Non-valvular atrial fibrillation

Interventions

Trade Name: Pradaxa Product Name: Pradaxa Pharmaceutical Form: Capsule INN or Proposed INN: DABIGATRAN ETEXILATE CAS Number: 211915-06-9 Trade Name: Xarelto Product Name: Xarelto Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who present with atrial fibrillation. 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: Valvular atrial fibrillation (mechanical heart valve or mitral stenosis), active malignancy, contraindication to anticoagulation (eg. severe bleeding tendency), severe thrombophilia (eg. lupus anticoagulant).

Design outcomes

Primary

Measure	Time frame
Main Objective: Assess the effects of direct oral anticoagulants dabigatran, rivaroxaban, apixaban and edoxaban on routinely used laboratory assays as well as special coagulation assays using blood samples from patients with non-valvular atrial fibrillation.;Secondary Objective: Not applicable;Primary end point(s): No clinical end points. Objective is study drug effects on patient samples on laboratory assays.;Timepoint(s) of evaluation of this end point: Not applicable	—

Measure

Time frame

Main Objective: Assess the effects of direct oral anticoagulants dabigatran, rivaroxaban, apixaban and edoxaban on routinely used laboratory assays as well as special coagulation assays using blood samples from patients with non-valvular atrial fibrillation.;Secondary Objective: Not applicable;Primary end point(s): No clinical end points. Objective is study drug effects on patient samples on laboratory assays.;Timepoint(s) of evaluation of this end point: Not applicable

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Finland

Contacts

Public ContactClinical Trials

Helsinki City Hospital Haartman

Outcome results

None listed

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