This study investigates how polymorphisms in the ABCB1 gene (which codes for the P-gp protein) affect drug levels in patients who experienced a serious bleeding or clotting event while taking new oral anticoagulants (blood thinners). It included patients aged 18-80 who had such a serious adverse event with these drugs. It is a non-phase study and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Patients aged \>18 and \<80 years of age * Patients admitted to the University Hospital of Besancon for a serious adverse event (major bleeding complication or thrombo-embolic event) occurring under treatment with any one of the three commercially available new oral anticoagulant agents (rivaroxaban, apixaban or dabigatran). * Patients must have social security coverage. * Patients must provide written informed consent. Exclusion Criteria: * Hemorrhagic complication from causes not related to drug therapy * Hemorrhagic complication occurring in patients not treated with oral anticoagulants at the time of the event * Thrombo-embolic complication occurring in patients not treated with oral anticoagulants at the time of the event * Legal incapacity, patients under judicial protection * Patients with no social security coverage * Patients unlikely to be compliant or anticipated by the investigator to be non-compliant with the study requirements * Patients in a wash-out period further to participation in a previous clinical trial