Anticoagulant Clinical Trial
— ANTIGOAGOfficial title:
Clinical, Biological and Genetic Determinants of Oral Anticoagulants' Activity
Verified date | October 2019 |
Source | University Hospital, Lille |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | University Hospital | Lille |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Lille |
France,
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 |
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