Evaluation of the Interference of Antithrombotic Agents With Laboratory Monitoring of Heparin Therapy

Blood Coagulation Tests Clinical Trial

— ACTARD  

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02839434
• Other study ID #: AGR_2015_27
• Status: Terminated
• Start date: December 2015
• Est. completion date: June 29, 2018

Study information

• Verified date: September 2017
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 105
• Est. completion date: June 29, 2018
• Est. primary completion date: June 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Coagulation Tests

Intervention

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.

Locations

Country	Name	City	State
France	Fondation ophtalmique Adolphe de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		1 hour