Determinants of Oral Anticoagulants' Activity

Anticoagulant Clinical Trial

— ANTIGOAG  

Official title:

Clinical, Biological and Genetic Determinants of Oral Anticoagulants' Activity

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03172546
• Other study ID #: 2014_26
• Secondary ID: 2015-A01596-43
• Status: Terminated
• Start date: July 6, 2017
• Est. completion date: October 15, 2019

Study information

• Verified date: October 2019
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: October 15, 2019
• Est. primary completion date: October 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anticoagulant

Intervention

Genetic:
• PK-PD genetic polymorphisms
PK-PD genetic polymorphisms analysis in patients receiving either anti-IIa or anti-Xa treatment

Locations

Country	Name	City	State
France	University Hospital	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of anticoagulant activity level	Multivariate analysis to determine clinical, biological or genetic predictors of anticoagulant activity level as measured by anti-IIa or anti-Xa activity	Baseline
Secondary	Occurence of any hemorrhagic complication	Multivariate analysis to determine clinical, biological or genetic predictors of hemorrhagic complications under direct oral anticoagulant	One year follow-up
Secondary	Occurence of any thrombotic complication	Multivariate analysis to determine clinical, biological or genetic predictors of thrombotic complications under direct oral anticoagulant	One year follow-up