Anticoagulant
Conditions
Keywords
direct oral anticoagulant, hemorrhagic complication, thrombotic complication, genetic polymorphisms
Brief summary
The primary objective of the present study is to determine the clinical, biological and genetic determinants of the anticoagulant activity in patients treated with either anti-IIa or anti Xa oral anticoagulants. The secondary objective is to determine the clinical, biological or genetic determinants of hemorrhagic or thrombotic complications during a one year follow-up. Results will lead to a better prediction of both drug response and risk of complications.
Detailed description
Direct oral anticoagulants are changing clinical practices but a better knowledge of factors that may predict both drug response and risk of complications is need. Anticoagulant activity is influenced by different factors. Because the biological activity is not easy to measure everywhere, it is important to clearly determine factors that are involved. A cohort of 550 patients that receive either an anti-IIa or an anti-Xa will be recruited. The primary objective is to determine clinical, biological and genetic determinants of anticoagulant activity. This objective will be assessed through a multivariate logistic regression (separately for anti-IIa and anti-Xa) with anticoagulant activity as dependent variable. Variables that will be included in the statistical model are those known or measured at the entry in the cohort such as : * Clinical factors : age, sex, weight, dosage and time of the last dose * Biological factors : serum creatinine level, plasma concentration of the drug * Genetic polymorphisms : Factor II and CES1 for anti-IIa drugs Factor X, CYP3, CYP3A4, CYP3A5 and ABCG2 for anti-Xa drugs. By using the same statistical approach and the same variables, predictive factors of either hemorrhagic or thrombotic events will also be evaluated on the whole cohort. The occurence of hemorrhagic and thrombotic complications will then be assessed through a phone call every 3 months during a one-year follow-up.
Interventions
GENETICPK-PD genetic polymorphisms
PK-PD genetic polymorphisms analysis in patients receiving either anti-IIa or anti-Xa treatment
Sponsors
University Hospital, Lille
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient receiving direct oral anticoagulant * Complete blood count and measure of hemostasis planned * Patient able to give consent * Patient with health insurance
Exclusion criteria
* Patient not able to consent * Patient under 18 years old * Patient refusal * Patient without health insurance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of anticoagulant activity level | Baseline | Multivariate analysis to determine clinical, biological or genetic predictors of anticoagulant activity level as measured by anti-IIa or anti-Xa activity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurence of any hemorrhagic complication | One year follow-up | Multivariate analysis to determine clinical, biological or genetic predictors of hemorrhagic complications under direct oral anticoagulant |
| Occurence of any thrombotic complication | One year follow-up | Multivariate analysis to determine clinical, biological or genetic predictors of thrombotic complications under direct oral anticoagulant |
Countries
France
Outcome results
None listed