Determinants of Oral Anticoagulants' Activity (ANTIGOAG)
Clinical, Biological and Genetic Determinants of Oral Anticoagulants' Activity
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
-
Lille, Frankrike, 59037
- University Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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 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 analysis in patients receiving either anti-IIa or anti-Xa treatment
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Measurement of anticoagulant activity level
Tidsramme: Baseline
|
Multivariate analysis to determine clinical, biological or genetic predictors of anticoagulant activity level as measured by anti-IIa or anti-Xa activity
|
Baseline
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Occurence of any hemorrhagic complication
Tidsramme: One year follow-up
|
Multivariate analysis to determine clinical, biological or genetic predictors of hemorrhagic complications under direct oral anticoagulant
|
One year follow-up
|
|
Occurence of any thrombotic complication
Tidsramme: One year follow-up
|
Multivariate analysis to determine clinical, biological or genetic predictors of thrombotic complications under direct oral anticoagulant
|
One year follow-up
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 2014_26
- 2015-A01596-43 (Annen identifikator: ID-RCB number, ANSM)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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