Oral AnticoagulantsPRADICONCT03150303
Oral Anticoagulant Peri-procedural Management in Patients Undergoing an Oral Surgery, Implantology or Periodontology
An observational study of Oral Anticoagulants and Invasive Procedure, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Patients receiving long-term oral anticoagulant (defined as duration of treatment of at least 1 month of Direct Oral Anticoagulant (DAOC) or Vitamin K Antagonist (VKA)) and referred for an invasive procedure (oral surgery, implantology or periodontology) to an oral surgeon taking part to the study will be included in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Anticoagulants, Invasive Procedure
- How many people
- 532 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jul 2017to 10 Jan 2020
- 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: Patients receiving oral anticoagulant undergoing an oral surgery, implantology or periodontology
Who may be able to join
- Patients receiving long-term oral anticoagulant (defined as duration of treatment of at least 1 month) and referred for an invasive procedure (oral surgery, implantology or periodontology) to an oral surgeon member of the SFCO taking part to the study.
- Each investigator will include 10 patients treated with long-term direct oral anticoagulants, and 10 consecutive patients treated with long-term Vitamin K Antagonists. For the oral anticoagulants group, inclusion will be continued until the inclusion of 333 patients for each molecule (apixaban, rivaroxaban, edoxaban).
Who cannot join
- Patients receiving both Vitamin K Antagonists and antiplatelet agents Patients receiving both direct oral anticoagulant and antiplatelet agents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Survey About Oral Anticoagulant Peri-procedural Management in Patients Undergoing an Oral Surgery, Implantology or Periodontology
Patients receiving long-term oral anticoagulant (defined as duration of treatment of at least 1 month of Direct Oral Anticoagulant (DAOC) or Vitamin K Antagonist (VKA)) and referred for an invasive procedure (oral surgery, implantology or periodontology) to an oral surgeon taking part to the study will be included in this prospective observational study.
The main composite outcome is the occurrence rate of hemorrhagic and/or thromboembolic events during the peri-procedural period (between 5 days before surgery plus 30 days after the invasive procedure).
- The secondary end-points will consist of identifying risk factors for bleeding during the peri-procedural period, risk factors for thromboembolic events during the peri-procedural period, the peri-procedural management of each treatment (VKA or DOAC), the prescribers involved in the possible change of anticoagulant prescription prior the oral surgery All outcome events will be blindly adjudicated by a central independent adjudication committee.
Read the detailed description
Manager Centre de Pharmaco-épidémiologie de l'AP-HP
Title Survey about oral anticoagulant peri-procedural management in patients undergoing an oral surgery, implantology or periodontology
Acronym PRADICO
Investigator Coordinator Isabelle MAHE
Number of investigational sites 100
Number of patients 2000
Population Patients receiving oral anticoagulant undergoing an oral surgery, implantology or periodontology
Research calendar Duration of inclusions: 1 year Duration of follow up: 30 days Study duration: 13 months
Selection criteria
Inclusion criteria :
Patients receiving long-term oral anticoagulant (defined as duration of treatment of at least 1 month) and referred for an invasive procedure (oral surgery, implantology or periodontology) to an oral surgeon member of the SFCO (Société Française de Chirurgie Orale) or a periodontologist member of the SFPIO (Société Française de Parodontologie et d'Implantologie Orale) taking part to the study.
Each investigator will include 10 patients treated with long-term DOAC, and 10 consecutive patients treated with long-term VKA. For the DOAC group, inclusion will be continued until the inclusion of 333 patients for each molecule (apixaban, rivaroxaban, edoxaban).
Non-inclusion criteria :
Patients receiving both VKA and antiplatelet agents Patients receiving both direct oral anticoagulant and antiplatelet agents
Objectives
Primary aim:
To assess the composite rate of thromboembolic and bleeding events occurring within the peri-procedural period, in patients on long-term DOAC and VKA and undergoing an oral surgery, implantology or periodontology.
Secondary aims :
- To identify risk factors for bleeding during the peri-procedural period
- To identify risk factors for thromboembolic events during the peri-procedural period
- To describe the peri-procedural management of each treatment (VKA or DOAC)
- To identify prescribers involved in the possible change of anticoagulant prescription prior the oral surgery
- To compare the risk of bleeding on DOAC and on VKA
- To compare the risk of thromboembolic complications on DOAC and on VKA
- To evaluate the net clinical benefit of DOAC compared to VKA treatment
Endpoints
Primary endpoint :
A composite outcome: the occurrence rate of hemorrhagic and/or thromboembolic events during the peri-procedural period.
Secondary endpoints :
- Incidence of bleeding events
- incidence of thromboembolic events
- net clinical benefit of DOAC compared to VKA
Methodology Prospective observational non interventional multicentric cohort study in adult population under long-term anticoagulant treatment (DOAC or VKA) and undergoing an oral, periodontal or implant surgery, by liberal practitioners or oral specialists at hospital.
Statistical analysis The occurrence rate of hemorrhagic or thromboembolic events during peri-procedural period will be calculated globally and in each group (VKA or DOAC) as a percentage with 95% CI.
Financements Company's grant
- BMS
- DAIICHI SANKYO
- Conditions
- Oral Anticoagulants, Invasive Procedure
- Keywords
- Periprocedural period, Anticoagulant treatment, Thromboembolic events, Bleeding events
- Medical subject headings
- Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin K Antagonists (VKA) | Patients on VKA | |
| Direct Oral Anticoagulant (DOAC) | Patients on OAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence rate of bleeding or thromboembolic events during the peri-procedural period
the occurrence rate of bleeding or thromboembolic events during the peri-procedural period defined as the period between 5 days before surgery plus 30 days after the invasive procedure (if no anticoagulant interruption) or 30 days after the resumption of oral anticoagulant (in case of an anticoagulant interruption).
Measured: Each patient will be followed for 30 days
Secondary outcomes (7)
risk factors for bleeding in the peri-procedural period
To identify risk factors for bleeding in the peri-procedural period
Measured: Each patient will be followed for 30 days.
risk factors for thromboembolic events in the peri-procedural period
To identify risk factors for thromboembolic events in the peri-procedural period
Measured: Each patient will be followed for 30 days.
peri-procedural management of each treatment (VKA, and each DOAC)
To describe the peri-procedural management of each treatment (VKA, and each DOAC)
Measured: Each patient will be followed for 30 days.
prescribers involved in the possible change of anticoagulant prescription prior the oral surgery
To identify prescribers involved in the possible change of anticoagulant prescription prior the oral surgery
Measured: Each patient will be followed for 30 days.
risk of bleeding on DOAC and on VKA
To compare the risk of bleeding on DOAC and on VKA
Measured: Each patient will be followed for 30 days.
risk of thromboembolic complications on DOAC and on VKA
To compare the risk of thromboembolic complications on DOAC and on VKA
Measured: Each patient will be followed for 30 days.
net clinical benefit of DOAC compared to VKA treatment
To evaluate the net clinical benefit of DOAC compared to VKA treatment
Measured: Each patient will be followed for 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start4 Jul 2017
- Primary completion4 Jul 2017
- Study completion10 Jan 2020
Why it stopped: Lack of budget
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 Oral AnticoagulantsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Prospective
- Enrolment
- 532 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb, Daiichi Sankyo
- Responsible party
- Sponsor
- Investigators
- Isabelle Mahé, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03150303
- Sponsor's protocol ID
- HAO-16007
- Acronym
- PRADICO
- Status last verified
- Apr 2017
- First submitted
- 9 May 2017
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Radoi L, Hajage D, Giboin C, Maman L, Monnet-Corti V, Descroix V, Mahe I. Perioperative management of oral anticoagulated patients undergoing an oral, implant, or periodontal procedure: a survey of practices of members of two dental scientific societies, the PRADICO study. Clin Oral Investig. 2019 Dec;23(12):4311-4323. doi: 10.1007/s00784-019-02877-1. Epub 2019 Mar 19.
PubMed 30887189
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey About Oral Anticoagulant Peri-procedural Management in Patients Undergoing an Oral Surgery, Implantology or Periodontology
- ClinicalTrials.gov ID
- NCT03150303
- Acronym / sponsor ID
- PRADICO / HAO-16007
- Conditions
- Oral Anticoagulants, Invasive Procedure
- Keywords
- Periprocedural period, Anticoagulant treatment, Thromboembolic events, Bleeding events
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of budget
- Enrolment
- 532 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb, Daiichi Sankyo
- Study start
- 4 Jul 2017 (actual)
- Primary completion
- 4 Jul 2017 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 12 May 2017 (actual)
- 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.
Patients receiving long-term oral anticoagulant (defined as duration of treatment of at least 1 month of Direct Oral Anticoagulant (DAOC) or Vitamin K Antagonist (VKA)) and referred for an invasive procedure (oral surgery, implantology or periodontology) to an oral surgeon taking part to the study will be included in this prospective observational study.
The main composite outcome is the occurrence rate of hemorrhagic and/or thromboembolic events during the peri-procedural period (between 5 days before surgery plus 30 days after the invasive procedure).
- The secondary end-points will consist of identifying risk factors for bleeding during the peri-procedural period, risk factors for thromboembolic events during the peri-procedural period, the peri-procedural management of each treatment (VKA or DOAC), the prescribers involved in the possible change of anticoagulant prescription prior the oral surgery All outcome events will be blindly adjudicated by a central independent adjudication committee.
Detailed description
Manager Centre de Pharmaco-épidémiologie de l'AP-HP
Title Survey about oral anticoagulant peri-procedural management in patients undergoing an oral surgery, implantology or periodontology
Acronym PRADICO
Investigator Coordinator Isabelle MAHE
Number of investigational sites 100
Number of patients 2000
Population Patients receiving oral anticoagulant undergoing an oral surgery, implantology or periodontology
Research calendar Duration of inclusions: 1 year Duration of follow up: 30 days Study duration: 13 months
Selection criteria
Inclusion criteria :
Patients receiving long-term oral anticoagulant (defined as duration of treatment of at least 1 month) and referred for an invasive procedure (oral surgery, implantology or periodontology) to an oral surgeon member of the SFCO (Société Française de Chirurgie Orale) or a periodontologist member of the SFPIO (Société Française de Parodontologie et d'Implantologie Orale) taking part to the study.
Each investigator will include 10 patients treated with long-term DOAC, and 10 consecutive patients treated with long-term VKA. For the DOAC group, inclusion will be continued until the inclusion of 333 patients for each molecule (apixaban, rivaroxaban, edoxaban).
Non-inclusion criteria :
Patients receiving both VKA and antiplatelet agents Patients receiving both direct oral anticoagulant and antiplatelet agents
Objectives
Primary aim:
To assess the composite rate of thromboembolic and bleeding events occurring within the peri-procedural period, in patients on long-term DOAC and VKA and undergoing an oral surgery, implantology or periodontology.
Secondary aims :
- To identify risk factors for bleeding during the peri-procedural period
- To identify risk factors for thromboembolic events during the peri-procedural period
- To describe the peri-procedural management of each treatment (VKA or DOAC)
- To identify prescribers involved in the possible change of anticoagulant prescription prior the oral surgery
- To compare the risk of bleeding on DOAC and on VKA
- To compare the risk of thromboembolic complications on DOAC and on VKA
- To evaluate the net clinical benefit of DOAC compared to VKA treatment
Endpoints
Primary endpoint :
A composite outcome: the occurrence rate of hemorrhagic and/or thromboembolic events during the peri-procedural period.
Secondary endpoints :
- Incidence of bleeding events
- incidence of thromboembolic events
- net clinical benefit of DOAC compared to VKA
Methodology Prospective observational non interventional multicentric cohort study in adult population under long-term anticoagulant treatment (DOAC or VKA) and undergoing an oral, periodontal or implant surgery, by liberal practitioners or oral specialists at hospital.
Statistical analysis The occurrence rate of hemorrhagic or thromboembolic events during peri-procedural period will be calculated globally and in each group (VKA or DOAC) as a percentage with 95% CI.
Financements Company's grant
- BMS
- DAIICHI SANKYO
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin K Antagonists (VKA) | – | –Patients on VKA |
| Direct Oral Anticoagulant (DOAC) | – | –Patients on OAD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving oral anticoagulant undergoing an oral surgery, implantology or periodontology
Key inclusion criteria (2 listed)
- Patients receiving long-term oral anticoagulant (defined as duration of treatment of at least 1 month) and referred for an invasive procedure (oral surgery, implantology or periodontology) to an oral surgeon member of the SFCO taking part to the study.
- Each investigator will include 10 patients treated with long-term direct oral anticoagulants, and 10 consecutive patients treated with long-term Vitamin K Antagonists. For the oral anticoagulants group, inclusion will be continued until the inclusion of 333 patients for each molecule (apixaban, rivaroxaban, edoxaban).
Key exclusion criteria (1 listed)
- Patients receiving both Vitamin K Antagonists and antiplatelet agents Patients receiving both direct oral anticoagulant and antiplatelet agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The occurrence rate of bleeding or thromboembolic events during the peri-procedural period
Time frame: Each patient will be followed for 30 days
the occurrence rate of bleeding or thromboembolic events during the peri-procedural period defined as the period between 5 days before surgery plus 30 days after the invasive procedure (if no anticoagulant interruption) or 30 days after the resumption of oral anticoagulant (in case of an anticoagulant interruption).
7 secondary outcomes
risk factors for bleeding in the peri-procedural period
Time frame: Each patient will be followed for 30 days.
risk factors for thromboembolic events in the peri-procedural period
Time frame: Each patient will be followed for 30 days.
peri-procedural management of each treatment (VKA, and each DOAC)
Time frame: Each patient will be followed for 30 days.
prescribers involved in the possible change of anticoagulant prescription prior the oral surgery
Time frame: Each patient will be followed for 30 days.
risk of bleeding on DOAC and on VKA
Time frame: Each patient will be followed for 30 days.
risk of thromboembolic complications on DOAC and on VKA
Time frame: Each patient will be followed for 30 days.
net clinical benefit of DOAC compared to VKA treatment
Time frame: Each patient will be followed for 30 days.
Results and safety
The study was stopped early (reason given: Lack of budget). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
- Derived from this study: PubMed 30887189Radoi L, Hajage D, Giboin C, Maman L, Monnet-Corti V, Descroix V, Mahe I. Perioperative management of oral anticoagulated patients undergoing an oral, implant, or periodontal procedure: a survey of practices of members of two dental scientific societies, the PRADICO study. Clin Oral Investig. 2019 Dec;23(12):4311-4323. doi: 10.1007/s00784-019-02877-1. Epub 2019 Mar 19.
- Individual participant dataSharing planned: No
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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.
Isabelle Mahé, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Oral Anticoagulants and Invasive Procedure, run by Assistance Publique - Hôpitaux de Paris 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 2 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: stopped early, as of the sponsor's last update on 19 Aug 2020. 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 was stopped early (reason given: Lack of budget). Results are not available in the source record.
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?
The occurrence rate of bleeding or thromboembolic events during the peri-procedural period (time frame: Each patient will be followed for 30 days). 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 NCT03150303, 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 19 Aug 2020.