Per-procedural Concentrations of Oral AnticoagulantsCORIDANCT02643992
Per-procedural Concentration of Direct Oral Anticoagulants
An observational study of Per-procedural Concentrations of Oral Anticoagulants, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Per-procedural Concentrations of Oral Anticoagulants
- What is being tested?
- DOAC concentration measurement
- How many people
- 270 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2013to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient undergoing invasive procedure and treated with DOAC
Who may be able to join
- patient over 18 years-old
- undergoing invasive procedure
- treated with DOAC
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
France1 site
Fondation Ophtalmologique Adolphe de Rothschild (FOR)
Paris, 75019
About this study
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.
- Being tested
- DOAC concentration measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DOAC concentration measurementOther
What is being measured
The primary outcome is the main question the study is designed to answer.
DOAC concentration
Measured: beginning of invasive procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startJun 2013
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Per-procedural Concentrations of Oral AnticoagulantsStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02643992
- Sponsor's protocol ID
- AGR_2014-13
- Acronym
- CORIDA
- Status last verified
- Feb 2017
- First submitted
- 30 Dec 2015
- Last updated
- 6 Feb 2017
- Results posted
- No
Publications
Godier A, Martin AC, Lessire S, Mullier F, Leblanc I, Gouin-Thibault I. Concentrations of direct oral anticoagulants according to guidelines for the periprocedural management of low bleeding risk procedures. Anaesth Crit Care Pain Med. 2020 Feb;39(1):121-122. doi: 10.1016/j.accpm.2019.04.004. Epub 2019 Apr 13. No abstract available.
PubMed 30991108
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Per-procedural Concentration of Direct Oral Anticoagulants
- ClinicalTrials.gov ID
- NCT02643992
- Acronym / sponsor ID
- CORIDA / AGR_2014-13
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- Jun 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 31 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient undergoing invasive procedure and treated with DOAC
Key inclusion criteria (3 listed)
- patient over 18 years-old
- undergoing invasive procedure
- treated with DOAC
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DOAC concentration measurement | Other | – |
Primary outcome
DOAC concentration
Time frame: beginning of invasive procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2017.
- Derived from this study: PubMed 30991108Godier A, Martin AC, Lessire S, Mullier F, Leblanc I, Gouin-Thibault I. Concentrations of direct oral anticoagulants according to guidelines for the periprocedural management of low bleeding risk procedures. Anaesth Crit Care Pain Med. 2020 Feb;39(1):121-122. doi: 10.1016/j.accpm.2019.04.004. Epub 2019 Apr 13. No abstract available.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Per-procedural Concentrations of Oral Anticoagulants, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DOAC concentration (time frame: beginning of invasive procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02643992, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2017.