NCT03150303

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
532

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

July 4, 2017

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2017

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2020

Completed
Last Updated

August 19, 2020

Status Verified

April 1, 2017

Enrollment Period

Same day

First QC Date

May 9, 2017

Last Update Submit

August 17, 2020

Conditions

Oral AnticoagulantsInvasive Procedure

Keywords

Periprocedural periodAnticoagulant treatmentThromboembolic eventsBleeding events

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • 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

    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.

  • +2 more secondary outcomes

Study Arms (2)

Vitamin K Antagonists (VKA)

Patients on VKA

Direct Oral Anticoagulant (DOAC)

Patients on OAD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • Patients receiving both Vitamin K Antagonists and antiplatelet agents Patients receiving both direct oral anticoagulant and antiplatelet agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Louis Mourier

Colombes, 92700, France

Location

Related Publications (1)

  • Radoi L, Hajage D, Giboin C, Maman L, Monnet-Corti V, Descroix V, Mahe I. Perioperative management of oral anticoagulated patients undergoing an oral, implant, or periodontal procedure: a survey of practices of members of two dental scientific societies, the PRADICO study. Clin Oral Investig. 2019 Dec;23(12):4311-4323. doi: 10.1007/s00784-019-02877-1. Epub 2019 Mar 19.

    PMID: 30887189DERIVED

MeSH Terms

Conditions

Thromboembolism

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Isabelle Mahé, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2017

First Posted

May 12, 2017

Study Start

July 4, 2017

Primary Completion

July 4, 2017

Study Completion

January 10, 2020

Last Updated

August 19, 2020

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)