Determinants of Oral Anticoagulants' Activity

NCT03172546 | Terminated

• 2 other identifiers: 2014_262015-A01596-43
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Anticoagulant

Keywords

direct oral anticoagulant; hemorrhagic complication; thrombotic complication; genetic polymorphisms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Occurence of any hemorrhagic complication

  One year follow-up

• Occurence of any thrombotic complication

  One year follow-up

Study Arms (2)

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

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

Interventions

PK-PD genetic polymorphisms GENETIC

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

Anti-IIa users; Anti-Xa users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patient receiving direct oral anticoagulant
• Complete blood count and measure of hemostasis planned
• Patient able to give consent
• Patient with health insurance

You may not qualify if:

• Patient not able to consent
• Patient under 18 years old
• Patient refusal
• Patient without health insurance

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

University Hospital

Lille, 59037, France

Location

Study Officials

• Dominique Deplanque, MD, PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: June 1, 2017
• Study Start: July 6, 2017
• Primary Completion: October 15, 2019
• Study Completion: October 15, 2019
• Last Updated: October 18, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)