Ignite Creation Date:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2026-01-27 @ 11:19 PM
Study NCT ID:
NCT02643992
Status:
COMPLETED
Last Update Posted:
2017-02-06
First Post:
2015-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Per-procedural Concentration of Direct Oral Anticoagulants
Sponsor:
Fondation Ophtalmologique Adolphe de Rothschild
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CORIDA
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: