Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
3 participants
OBSERVATIONAL
2017-07-06
2019-10-15
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Anti-IIa users
Determination of predictors of anticoagulant activity in a prospective cohort of patients using oral anti IIa anticoagulant including analysis of PK-PD genetic polymorphisms
PK-PD genetic polymorphisms
PK-PD genetic polymorphisms analysis in patients receiving either anti-IIa or anti-Xa treatment
Anti-Xa users
Determination of predictors of anticoagulant activity in a prospective cohort of patients using oral anti Xa anticoagulant including analysis of PK-PD genetic polymorphisms
PK-PD genetic polymorphisms
PK-PD genetic polymorphisms analysis in patients receiving either anti-IIa or anti-Xa treatment
Interventions
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PK-PD genetic polymorphisms
PK-PD genetic polymorphisms analysis in patients receiving either anti-IIa or anti-Xa treatment
Eligibility Criteria
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Inclusion Criteria
* Complete blood count and measure of hemostasis planned
* Patient able to give consent
* Patient with health insurance
Exclusion Criteria
* Patient under 18 years old
* Patient refusal
* Patient without health insurance
18 Years
ALL
No
Sponsors
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University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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Dominique Deplanque, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Lille
Locations
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University Hospital
Lille, , France
Countries
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Other Identifiers
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2015-A01596-43
Identifier Type: OTHER
Identifier Source: secondary_id
2014_26
Identifier Type: -
Identifier Source: org_study_id
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