Clinical trial NCT03172546: Determinants of Oral Anticoagulants' Activity
Official title: Clinical, Biological and Genetic Determinants of Oral Anticoagulants' Activity
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Anticoagulant
Keywords: direct oral anticoagulant
hemorrhagic complication
thrombotic complication
genetic polymorphisms
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2017-06-01
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be composed by all patient receiving a direct oral anticoagulant inside the University Hospital whatever the clinical indication

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.

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

Primary outcomes:
measure: Measurement of anticoagulant activity level
timeFrame: Baseline
Secondary outcomes:
measure: Occurence of any hemorrhagic complication
timeFrame: One year follow-up
measure: Occurence of any thrombotic complication
timeFrame: One year follow-up
Other outcomes:
Locations:
city: Lille
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Lille
name: Dominique Deplanque, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: