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

August 17, 2020 updated by: Assistance Publique - Hôpitaux de Paris

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).

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.

Study Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Actual)

532

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Colombes, France, 92700
        • Louis Mourier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients receiving oral anticoagulant undergoing an oral surgery, implantology or periodontology

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Vitamin K Antagonists (VKA)
Patients on VKA
Direct Oral Anticoagulant (DOAC)
Patients on OAD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Each patient will be followed for 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
risk factors for bleeding in the peri-procedural period
Time Frame: Each patient will be followed for 30 days.
To identify risk factors for bleeding in the peri-procedural period
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.
To identify 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)
Time Frame: Each patient will be followed for 30 days.
To describe the 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
Time Frame: Each patient will be followed for 30 days.
To identify 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
Time Frame: Each patient will be followed for 30 days.
To compare the risk of bleeding on DOAC and on VKA
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.
To compare the 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
Time Frame: Each patient will be followed for 30 days.
To evaluate the net clinical benefit of DOAC compared to VKA treatment
Each patient will be followed for 30 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Bristol-Myers Squibb
Daiichi Sankyo, Inc.

Investigators

  • Principal Investigator: Isabelle Mahé, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 4, 2017

Primary Completion (ACTUAL)

July 4, 2017

Study Completion (ACTUAL)

January 10, 2020

Study Registration Dates

First Submitted

May 9, 2017

First Submitted That Met QC Criteria

May 9, 2017

First Posted (ACTUAL)

May 12, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 19, 2020

Last Update Submitted That Met QC Criteria

August 17, 2020

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HAO-16007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Invasive Procedure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe