To evaluate the safety and efficacy of delayed interruption of therapy with direct-acting oral anticoagulants (DOACs) in patients undergoing oral surgery classified as having moderate bleeding risk.

Haemorrhagic risk of direct oral anticoagulants (DOACs) in patients undergoing oral surgery - DOACs and oral surgery

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-006514-37-IT

Enrollment

400

Registered

2022-08-05

Start date

2023-02-08

Completion date

Unknown

Last updated

2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients on direct acting oral anticoagulants (DOACs) who are to undergo oral surgery. MedDRA version: 20.0 Level: HLGT Classification code 10007521 Term: Cardiac arrhythmias System Organ Class: 10007541 - Cardiac disorders

Interventions

Product Name: Eliquis Product Code: [041225032/E] Pharmaceutical Form: Tablet INN or Proposed INN: APIXABAN Current Sponsor code: 041225095 Concentration unit: mg milligram(s) Concentration type: up t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Adult patients of all ages receiving DOACs who have indications for the following outpatient oral surgery and who are attributed a risk of moderate postoperative bleeding: To multiple dental avulsions of teeth affected by carious and / or periodontal pathology; B surgical avulsion of teeth in dental inclusion and disodontiasis; C biopsy samples of the mucous membrane of the oral cavity and of the bone of the maxillary bases for diagnostic purposes; D excision of inflammatory odontogenic cystic neoformations or from endosseous development; E Bone Courettage by excision of necrotic bone. 2) Patients able to understand the nature of the study and the treatments, to provide written informed consent and willing to undergo specific pre- and post-operative checks and tests. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 199

Exclusion criteria

Exclusion criteria: Exclusion criteria 1) Patients not taking DOAC. 2) Patients requiring oral surgery who are attributed a low or high risk of postoperative haemorrhage such as simple single extractions or surgical procedures involving bone resections or osteotomies. 3) Patients on anticoagulant treatment who require oral surgery for which cardiologists have expressed a justified request for exclusion.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the safety and efficacy of delayed discontinuation of DOAC anticoagulant therapy in patients undergoing oral surgery classified as moderate bleeding risk.;Secondary Objective: Not applicable;Primary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Italy

Contacts

Public ContactU.O. Chirurgia Maxillo-Facciale

EE Ospedale Gen.Reg. "F.Miulli"

a.maggi@miulli.it

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026