Per-procedural Concentrations of Oral Anticoagulants Clinical Trial
— CORIDA| Verified date | February 2017 |
| Source | Fondation Ophtalmologique Adolphe de Rothschild |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 270 |
| Est. completion date | January 2016 |
| Est. primary completion date | January 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - patient over 18 years-old - undergoing invasive procedure - treated with DOAC Exclusion Criteria: |
| Country | Name | City | State |
|---|---|---|---|
| France | Fondation Ophtalmologique Adolphe de Rothschild (FOR) | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Fondation Ophtalmologique Adolphe de Rothschild |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | DOAC concentration | beginning of invasive procedure |