Survey About Oral Anticoagulant Peri-procedural Management in Patients Undergoing an Oral Surgery, Implantology or Periodontology
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 532
- Locations
- 1
- Primary Endpoint
- The occurrence rate of bleeding or thromboembolic events during the peri-procedural period
Study Overview
Brief 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 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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 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).
Exclusion Criteria
- •Patients receiving both Vitamin K Antagonists and antiplatelet agents Patients receiving both direct oral anticoagulant and antiplatelet agents
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- risk factors for thromboembolic events in the peri-procedural period(Each patient will be followed for 30 days.)
- peri-procedural management of each treatment (VKA, and each DOAC)(Each patient will be followed for 30 days.)
- prescribers involved in the possible change of anticoagulant prescription prior the oral surgery(Each patient will be followed for 30 days.)
- risk of bleeding on DOAC and on VKA(Each patient will be followed for 30 days.)
- risk factors for bleeding in the peri-procedural period(Each patient will be followed for 30 days.)
- risk of thromboembolic complications on DOAC and on VKA(Each patient will be followed for 30 days.)
- net clinical benefit of DOAC compared to VKA treatment(Each patient will be followed for 30 days.)