Evaluation of the Interference of Antithrombotic Agents With Laboratory Monitoring of Heparin Therapy (ACTARD)

September 17, 2018 updated by: Fondation Ophtalmologique Adolphe de Rothschild

Oral anticoagulants are increasingly prescribed and the are not discontinued for invasive cardiac procedures .

Additional parenteral anticoagulation is necessary for these procedures (FA ablation and invasive coronary explorations).

The unfractionated heparin doses are adapted on a monitoring test heparin, activated clotting time (ACT) with the aim of obtaining and maintaining an ACT > 300-400 sec. This goal is the same whether the patient is on oral anticoagulant treatment or not, and regardless of the initial level of anticoagulation.

The effects of oral anticoagulants on routine coagulation tests (PT, APTT, TT) are well documented, but few data have been published on the effects of heparin monitoring tests, particularly on the ACT.

The aim of this stuy is to redefine the target values of ACT and unfractionated heparin doses to administer to optimize the efficacy / safety of invasive procedures in cardiology.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75019
        • Fondation ophtalmique Adolphe de Rothschild

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult treated with oral anticoagulant at curative dose

Description

Inclusion Criteria:

  • patient treated with oral anticoagulant at curative dose and requiring a requiring a venous blood sample for his management

Exclusion Criteria:

  • opposition to the patient to participate to the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treated with oral anticoagulants
Ex vivo study using blood samples from patients treated with oral anticoagulant (direct oral anticoagulants or AVK) at curative dose, taken in the usual cardiac monitoring.
Procedure: Blood sample
This blood sample does not require specific puncture because it is made on the occasion of a sample justified by the patient monitoring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlation between the plasmatic concentration in direct oral anticoagulants (DOAC) or International Normalized Ratio for AVK and the value of the Activated clotting time (ACT)
Time Frame: 1 hour
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

June 29, 2018

Study Completion (Actual)

June 29, 2018

Study Registration Dates

First Submitted

July 12, 2016

First Submitted That Met QC Criteria

July 18, 2016

First Posted (Estimate)

July 21, 2016

Study Record Updates

Last Update Posted (Actual)

September 18, 2018

Last Update Submitted That Met QC Criteria

September 17, 2018

Last Verified

September 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • AGR_2015_27

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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