NCT03477331

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
444

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2018

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 2, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 26, 2018

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

6 years

First QC Date

February 2, 2018

Last Update Submit

April 8, 2024

Conditions

Cardiovascular Diseases

Keywords

Direct oral anticoagulantP2Y12 inhibitorsPhysiologically-based pharmacokinetic model (PBPK)Population-based pharmacokinetic model (POPPK)

Outcome Measures

Primary Outcomes (1)

  • Area Under the Curve (AUC)

    Difference between observed and PBPK model-predicted AUC (mean prediction error)

    2 years

Secondary Outcomes (5)

  • Trough Concentration (Cmin)

    2 years

  • Area Under the Curve (AUC) (stability of the model over time)

    2 years

  • Major bleeding event-free survival

    2 years

  • Peak concentration (Cmax)

    2 years

  • Thrombosis event-free survival

    2 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hospitalized patients

You may qualify if:

  • Hospitalized patients at any of the Geneva University Hospitals 18 yo and older
  • Treated with DOAC (dabigatran, rivaroxaban, apixaban) or/and P2Y12 (clopidogrel, ticragrelor et prasugel) at the time of study blood sampling
  • Understanding of French language and able to give an inform consent.

You may not qualify if:

  • Patients with a reduced life span (\<6 mois)
  • Change in dosage or cessation of the DOAC or P2Y12 taken by the participant follow up data will be censored at the time of change.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopitaux universitaires de Genève, 4 rue Gabrielle-Perret-Gentil

Geneva, Canton of Geneva, 1205, Switzerland

Location

Related Publications (4)

  • Terrier J, Gaspar F, Gosselin P, Raboud O, Lenoir C, Rollason V, Csajka C, Samer C, Fontana P, Daali Y, Reny JL; OptimAT study group. Apixaban and rivaroxaban's physiologically-based pharmacokinetic model validation in hospitalized patients: A first step for larger use of a priori modeling approach at bed side. CPT Pharmacometrics Syst Pharmacol. 2023 Dec;12(12):1872-1883. doi: 10.1002/psp4.13036. Epub 2023 Oct 4.

    PMID: 37794718BACKGROUND

  • Gaspar F, Terrier J, Favre S, Gosselin P, Fontana P, Daali Y, Lenoir C, Samer CF, Rollason V, Reny JL, Csajka C, Guidi M. Population pharmacokinetics of apixaban in a real-life hospitalized population from the OptimAT study. CPT Pharmacometrics Syst Pharmacol. 2023 Oct;12(10):1541-1552. doi: 10.1002/psp4.13032. Epub 2023 Sep 18.

    PMID: 37723920BACKGROUND

  • Achour B, Gosselin P, Terrier J, Gloor Y, Al-Majdoub ZM, Polasek TM, Daali Y, Rostami-Hodjegan A, Reny JL. Liquid Biopsy for Patient Characterization in Cardiovascular Disease: Verification against Markers of Cytochrome P450 and P-Glycoprotein Activities. Clin Pharmacol Ther. 2022 Jun;111(6):1268-1277. doi: 10.1002/cpt.2576. Epub 2022 Mar 28.

    PMID: 35262906BACKGROUND

  • Gaspar F, Jacost-Descombes C, Gosselin P, Reny JL, Guidi M, Csajka C, Samer C, Daali Y, Terrier J. Improving Understanding of Fexofenadine Pharmacokinetics to Assess Pgp Phenotypic Activity in Older Adult Patients Using Population Pharmacokinetic Modeling. Clin Pharmacokinet. 2025 Feb;64(2):275-283. doi: 10.1007/s40262-024-01470-4. Epub 2025 Jan 11.

    PMID: 39798016DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Jean-Luc Reny, Prof

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

February 2, 2018

First Posted

March 26, 2018

Study Start

January 14, 2018

Primary Completion

January 31, 2024

Study Completion

January 31, 2024

Last Updated

April 10, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)