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

Invasive Procedure Clinical Trial

— PRADICO  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03150303
• Other study ID #: HAO-16007
• Status: Terminated
• Start date: July 4, 2017
• Est. completion date: January 10, 2020

Study information

• Verified date: April 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 532
• Est. completion date: January 10, 2020
• Est. primary completion date: July 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Invasive Procedure
• Oral Anticoagulants

Locations

Country	Name	City	State
France	Louis Mourier	Colombes

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Bristol-Myers Squibb, Daiichi Sankyo, Inc.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Each patient will be followed for 30 days
Secondary	risk factors for bleeding in the peri-procedural period	To identify risk factors for bleeding in the peri-procedural period	Each patient will be followed for 30 days.
Secondary	risk factors for thromboembolic events in the peri-procedural period	To identify risk factors for thromboembolic events in the peri-procedural period	Each patient will be followed for 30 days.
Secondary	peri-procedural management of each treatment (VKA, and each DOAC)	To describe the peri-procedural management of each treatment (VKA, and each DOAC)	Each patient will be followed for 30 days.
Secondary	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	Each patient will be followed for 30 days.
Secondary	risk of bleeding on DOAC and on VKA	To compare the risk of bleeding on DOAC and on VKA	Each patient will be followed for 30 days.
Secondary	risk of thromboembolic complications on DOAC and on VKA	To compare the risk of thromboembolic complications on DOAC and on VKA	Each patient will be followed for 30 days.
Secondary	net clinical benefit of DOAC compared to VKA treatment	To evaluate the net clinical benefit of DOAC compared to VKA treatment	Each patient will be followed for 30 days.