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Clinical Trials/NCT03172546
NCT03172546
Terminated
Not Applicable

Clinical, Biological and Genetic Determinants of Oral Anticoagulants' Activity

University Hospital, Lille1 site in 1 country3 target enrollmentJuly 6, 2017
ConditionsAnticoagulant

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anticoagulant
Sponsor
University Hospital, Lille
Enrollment
3
Locations
1
Primary Endpoint
Measurement of anticoagulant activity level
Status
Terminated
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 6, 2017
End Date
October 15, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Lille
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Measurement of anticoagulant activity level

Time Frame: Baseline

Multivariate analysis to determine clinical, biological or genetic predictors of anticoagulant activity level as measured by anti-IIa or anti-Xa activity

Secondary Outcomes

  • Occurence of any hemorrhagic complication(One year follow-up)
  • Occurence of any thrombotic complication(One year follow-up)

Study Sites (1)

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