Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-01-05 @ 2:19 AM
Study NCT ID:
NCT03150303
Status:
TERMINATED
Last Update Posted:
2020-08-19
First Post:
2017-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Anticoagulant Peri-procedural Management in Patients Undergoing an Oral Surgery, Implantology or Periodontology
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Survey About Oral Anticoagulant Peri-procedural Management in Patients Undergoing an Oral Surgery, Implantology or Periodontology
Status:
TERMINATED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of budget
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRADICO
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).
0\. 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.
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).
0\. 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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: