ClinicalTrials.gov
ClinicalTrials.gov Menu

Per-procedural Concentration of Direct Oral Anticoagulants (CORIDA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02643992
Recruitment Status : Completed
First Posted : December 31, 2015
Last Update Posted : February 6, 2017
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary:

Background: Peri-procedural management of direct oral anticoagulants (DOAC) is challenging. The optimal duration of pre-procedural discontinuation that guarantees a minimal DOAC concentration ([DOAC]) at surgery is unknown. The usual 48-hour discontinuation might not be sufficient for all patients.

Objectives: To investigate the factors associated with per-procedural [DOAC]. To test the hypothesis that a 48-hour DOAC discontinuation is not sufficient to ensure a minimal perprocedural [DOAC], defined as [DOAC] < 30 ng/mL.

Methods: Patients treated with DOAC, and requiring any invasive procedure will be included in this multicentre, prospective, observational study. [DOAC], will be measured during invasive procedure.


Condition or disease Intervention/treatment
Per-procedural Concentrations of Oral Anticoagulants Other: DOAC concentration measurement

Study Type : Observational
Actual Enrollment : 270 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Study Start Date : June 2013
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners




Primary Outcome Measures :
  1. DOAC concentration [ Time Frame: beginning of invasive procedure ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
patient undergoing invasive procedure and treated with DOAC
Criteria

Inclusion Criteria:

  • patient over 18 years-old
  • undergoing invasive procedure
  • treated with DOAC

Exclusion Criteria:


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): NCT02643992


Locations
France
Fondation Ophtalmologique Adolphe de Rothschild (FOR)
Paris, France, 75019
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild

Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT02643992     History of Changes
Other Study ID Numbers: AGR_2014-13
First Posted: December 31, 2015    Key Record Dates
Last Update Posted: February 6, 2017
Last Verified: February 2017