An observational study in Cardiovascular Diseases, sponsored by University Hospital, Geneva. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-10.
Sponsored by University Hospital, Geneva · Observational
The main goal of the OptimAT study main goal is to validate a PBPK model for 3 direct oral anticoagulants (rivaroxaban, apixaban, dabigatran) and 3 P2Y12 inhibitors (clopidogrel, ticagrelor, prasugrel) in hospitalized patients.
Patients treated with antithrombotics are at risk of both severe ischemic and bleeding events. However, current clinical scores are insufficiently discriminant to predict the most favorable drug and dosing for an improved net clinical benefit. Physiologically and population-based pharmacokinetic models (PBPK and POPPK respectively) incorporate substrate specific properties obtained from experimental in-vitro experiments as well as patients' demographic, genetic and physiological in vivo data in order to characterize the dose-concentration relationships. As such, they can be used to simulate and predict PK profiles accounting for specific patients' characteristics and are the basis of dosing optimization. These models could be a valuable tool to predict antithrombotic blood concentration in a given patient. Our main goal is to elaborate predictive models characterizing the dose-concentration relationship with influencing variables of three direct oral anticoagulants (DOAC) (rivaroxaban, apixaban, dabigatran) and three P2Y12 inhibitors (clopidogrel, prasugrel, ticagrelor) in hospitalized patients, which will serve as basis for drug selection and dosage optimization.
Hospitalized patients
Inclusion Criteria:
Exclusion Criteria:
Area Under the Curve (AUC)
Difference between observed and PBPK model-predicted AUC (mean prediction error)
Time frame: 2 years
Trough Concentration (Cmin)
Difference between observed and PBPK model-predicted Cmin (mean prediction error)
Time frame: 2 years
Area Under the Curve (AUC) (stability of the model over time)
Difference between observed and model-predicted AUC during patients' rehospitalization (stability of the model over time)
Time frame: 2 years
Major bleeding event-free survival
Major bleeding event-free survival according to drug exposure (AUC) during a prospective during a follow-up of two years for DOACs (dabigatran, rivaroxaban, apixaban) and P2Y12 receptor inhibitors (clopidogrel, ticragrelor, prasugel)
Time frame: 2 years
Peak concentration (Cmax)
Difference between observed and PBPK model-predicted Cmax (mean prediction error)
Time frame: 2 years
Thrombosis event-free survival
Thrombosis event-free survival according to drug exposure (AUC) during a prospective during a follow-up of two years for DOACs (dabigatran, rivaroxaban, apixaban) and P2Y12 receptor inhibitors (clopidogrel, ticragrelor, prasugel)
Time frame: 2 years
Plan to share: No
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University Hospital, Geneva