NCT03172546

Determinants of Oral Anticoagulants' Activity

Clinical, Biological and Genetic Determinants of Oral Anticoagulants' Activity

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 3 (actual)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anticoagulant

Interventions

Type	Name	Description
GENETIC	PK-PD genetic polymorphisms	PK-PD genetic polymorphisms analysis in patients receiving either anti-IIa or anti-Xa treatment

Timeline

• Start date: 2017-07-06
• Primary completion: 2019-10-15
• Completion: 2019-10-15
• First posted: 2017-06-01
• Last updated: 2019-10-18

Locations

1 site across 1 country: France