Antithrombotics' Therapeutic Optimization in Hospitalized Patients Using Physiologically- and Population-based Pharmacokinetic Modeling (OptimAT)
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| ClinicalTrials.gov Identifier: NCT03477331 |
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Recruitment Status :
Recruiting
First Posted : March 26, 2018
Last Update Posted : October 6, 2021
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Sponsor:
University Hospital, Geneva
Information provided by (Responsible Party):
Jean-Luc Reny, University Hospital, Geneva
| Tracking Information | |||||||||
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| First Submitted Date | February 2, 2018 | ||||||||
| First Posted Date | March 26, 2018 | ||||||||
| Last Update Posted Date | October 6, 2021 | ||||||||
| Actual Study Start Date | January 14, 2018 | ||||||||
| Estimated Primary Completion Date | January 14, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
Area Under the Curve (AUC) [ Time Frame: 2 years ] Difference between observed and PBPK model-predicted AUC (mean prediction error)
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Antithrombotics' Therapeutic Optimization in Hospitalized Patients Using Physiologically- and Population-based Pharmacokinetic Modeling | ||||||||
| Official Title | Antithrombotics' Therapeutic Optimization in Hospitalized Patients Using Physiologically- and Population-based Pharmacokinetic Modeling | ||||||||
| 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. | ||||||||
| Detailed Description | 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. | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: whole blood
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| Sampling Method | Probability Sample | ||||||||
| Study Population | Hospitalized patients | ||||||||
| Condition | Cardiovascular Diseases | ||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
600 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | January 14, 2022 | ||||||||
| Estimated Primary Completion Date | January 14, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | Switzerland | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03477331 | ||||||||
| Other Study ID Numbers | 2017-00225 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Current Responsible Party | Jean-Luc Reny, University Hospital, Geneva | ||||||||
| Original Responsible Party | Same as current | ||||||||
| Current Study Sponsor | University Hospital, Geneva | ||||||||
| Original Study Sponsor | Same as current | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | University Hospital, Geneva | ||||||||
| Verification Date | September 2021 | ||||||||