Oral Anticoagulant Peri-procedural Management in Patients Undergoing an Oral Surgery, Implantology or Periodontology

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

532 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-04

Study Completion Date

2020-01-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Activates Charcoal for Patients Undergoing Invasive Procedure Delayed Due to Direct Oral Anticoagulants

NCT02969746

Anticoagulants; Circulating, Hemorrhagic Disorder

WITHDRAWN PHASE4

Periprocedural Direct Oral Anticoagulant Management

NCT03182218

Periprocedural Complication

COMPLETED

DOAC Versus VKA After Cardiac Surgery

NCT04002011

Anticoagulant-induced Bleeding

WITHDRAWN PHASE2

Reversal Agent Use in Patients Treated With Direct Oral Anticoagulants or Vitamin K Antagonists (RADOA). Focus on New Antidots

NCT03537521

Severe Bleeding Urgent Surgery

WITHDRAWN

The Perioperative Management of Anti-thrombotic Drug Registry

NCT03695159

Surgery Perioperative/Postoperative Complications

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Oral Anticoagulants Invasive Procedure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vitamin K Antagonists (VKA)

Patients on VKA

No interventions assigned to this group

Direct Oral Anticoagulant (DOAC)

Patients on OAD

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).