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Determinants of Oral Anticoagulants' Activity (ANTIGOAG)

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ClinicalTrials.gov Identifier: NCT03172546
Recruitment Status : Terminated (not sufficiency inclusion)
First Posted : June 1, 2017
Last Update Posted : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

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
Anticoagulant 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.


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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 : July 6, 2017
Actual Primary Completion Date : October 15, 2019
Actual Study Completion Date : October 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Group/Cohort 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




Primary Outcome Measures :
  1. Measurement of anticoagulant activity level [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: One year follow-up ]
    Multivariate analysis to determine clinical, biological or genetic predictors of thrombotic complications under direct oral anticoagulant



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03172546


Locations
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France
University Hospital
Lille, France, 59037
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Dominique Deplanque, MD, PhD University Hospital, Lille

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03172546     History of Changes
Other Study ID Numbers: 2014_26
2015-A01596-43 ( Other Identifier: ID-RCB number, ANSM )
First Posted: June 1, 2017    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Anticoagulants