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ANTIGOAG: Determinants of Oral Anticoagulants' Activity

Sponsor
University Hospital, Lille (Other)
Overall Status
Terminated
CT.gov ID
NCT03172546
Collaborator
(none)
3
Enrollment
1
Location
27.3
Actual Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Genetic: PK-PD genetic polymorphisms

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.

Study Design

Study Type:
Observational
Actual Enrollment :
3 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Clinical, Biological and Genetic Determinants of Oral Anticoagulants' Activity
Actual Study Start Date :
Jul 6, 2017
Actual Primary Completion Date :
Oct 15, 2019
Actual Study Completion Date :
Oct 15, 2019

Arms and Interventions

Arm Intervention/Treatment
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

Genetic: 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

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

Outcome Measures

Primary Outcome Measures

  1. Measurement of anticoagulant activity level [Baseline]

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

Secondary Outcome Measures

  1. Occurence of any hemorrhagic complication [One year follow-up]

    Multivariate analysis to determine clinical, biological or genetic predictors of hemorrhagic complications under direct oral anticoagulant

  2. Occurence of any thrombotic complication [One year follow-up]

    Multivariate analysis to determine clinical, biological or genetic predictors of thrombotic complications under direct oral anticoagulant

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Lille France 59037

Sponsors and Collaborators

  • University Hospital, Lille

Investigators

  • Principal Investigator: Dominique Deplanque, MD, PhD, University Hospital, Lille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT03172546
Other Study ID Numbers:
  • 2014_26
  • 2015-A01596-43
First Posted:
Jun 1, 2017
Last Update Posted:
Oct 18, 2019
Last Verified:
Oct 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Lille
direct oral anticoagulant
hemorrhagic complication
thrombotic complication
genetic polymorphisms

Study Results

No Results Posted as of Oct 18, 2019