Study of direct oral anticoagulants (medications that help prevent blood clots) in lung transplant patients

Pharmacokinetics and pharmacodynamics of direct oral anticoagulants in lung transplant patients: a prospective study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN10003031

Enrollment

Registered

2024-07-11

Start date

2022-11-02

Completion date

Unknown

Last updated

2024-07-22

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

Conditions

Direct oral anticoagulant use in lung transplant patients Haematological Disorders

Interventions

Pharmacokinetic study Apixaban, edoxaban and rivaroxaban plasma levels will be estimated using a calibrated chromogenic anti-Xa assay, the STA®-Liquid anti-Xa (Diagnostica Stago, Asnière, France). Dab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. = 18 years old; 2. Medical history of lung transplant; 3. DOAC prescription (apixaban, dabigatran etexilate, edoxaban or rivaroxaban) for (i) the treatment and secondary prevention of VTE or (ii) stroke prevention in NVAF. 4. DOAC taken for at least three days. 5. Both inpatients and outpatients are considered for inclusion.

Exclusion criteria

Exclusion criteria: Patient hospitalized in intensive care unit at inclusion.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic study: Concentration-time data will be analyzed using non-compartmental PK to derive PK parameters. DOAC concentrations will be measured in the morning just before DOAC intake (T0), then 1, 2, 3, 4, 6 and 8 hours after DOAC intake. Whenever possible, DOAC concentrations will also be measured the next morning just before DOAC intake (T24) to assess inter-individual variability. Apixaban, edoxaban and rivaroxaban plasma concentrations will be estimated using a calibrated chromogenic anti-Xa assay, the STA®-Liquid anti-Xa (Diagnostica Stago, Asnière, France), using dedicated calibrators from Stago. Dabigatran plasma levels will be estimated with an ecarin-based assay (STA®-ECA II, Diagnostica Stago). 1. Peak concentration (Cmax) 2. Time to reach peak concentration (Tmax) 3. Area under the concentration curve (AUC) extrapolated to infinity 4. The terminal elimination half-life 5. The apparent volume of distribution (Vd/F) 6. The apparent clearance (CL/F). Pharmacodynamic study: Thrombin generation will be measured at through (just before DOAC intake) and at peak (3 hours after DOAC intake) on the ST-Genesia system with STG-DrugScreen and STG-ThromboScreen reagent and the following parameters will be evaluated: 1. Lag time 2. Peak height 3. Time to peak 4. Endogenous thrombin potential (ETP) 5. Velocity index	—

Measure

Time frame

Pharmacokinetic study: Concentration-time data will be analyzed using non-compartmental PK to derive PK parameters. DOAC concentrations will be measured in the morning just before DOAC intake (T0), then 1, 2, 3, 4, 6 and 8 hours after DOAC intake. Whenever possible, DOAC concentrations will also be measured the next morning just before DOAC intake (T24) to assess inter-individual variability. Apixaban, edoxaban and rivaroxaban plasma concentrations will be estimated using a calibrated chromogenic anti-Xa assay, the STA®-Liquid anti-Xa (Diagnostica Stago, Asnière, France), using dedicated calibrators from Stago. Dabigatran plasma levels will be estimated with an ecarin-based assay (STA®-ECA II, Diagnostica Stago). 1. Peak concentration (Cmax) 2. Time to reach peak concentration (Tmax) 3. Area under the concentration curve (AUC) extrapolated to infinity 4. The terminal elimination half-life 5. The apparent volume of distribution (Vd/F) 6. The apparent clearance (CL/F). Pharmacodynamic study: Thrombin generation will be measured at through (just before DOAC intake) and at peak (3 hours after DOAC intake) on the ST-Genesia system with STG-DrugScreen and STG-ThromboScreen reagent and the following parameters will be evaluated: 1. Lag time 2. Peak height 3. Time to peak 4. Endogenous thrombin potential (ETP) 5. Velocity index

—

Secondary

Measure	Time frame
Clinical outcomes during the 12-month follow-up period (or until the end of the study, depending on which comes first) measured using patient records: 1. Any documented thromboembolic event 2. Any documented bleeding event	—

Countries

Belgium

Contacts

Public ContactMichael Hardy

michael.hardy@uclouvain.be+32 81 42 39 13

Outcome results

None listed

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