Clinical trial NCT03181386: Tooth Extraction in Patients With Atrial Fibrillation in Use of New Oral Anticoagulants
Official title: Prospective Study of the Assessment of the Dental Protocol for Tooth Extraction in Patients With Atrial Fibrillation in Continuous Use of New Oral Anticoagulants: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Periodontal Disease
Hemorrhage
Keywords: Dabigatran
Rivaroxaban
Apixaban
Warfarin
Tooth Extraction
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2017-06-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the safety of a protocol which does not suspend the new oral anticoagulants (dabigatran, rivaroxaban and apixaban) in front of dental extractions in patients with non-valvular atrial fibrillation.

Detailed description: The sample will be divided into three groups according to the pharmacokinetics of the oral anticoagulant: rivaroxaban 1x/day (group 1); dabigatran and apixabana 2x/day (group 2) and warfarin (control group). Extraction of one to three teeth will be scheduled, in the valley of the new oral anticoagulants' concentration, considered the period of smallest haemorrhagic risk without suspension. In group 1 the surgery will be scheduled 14 hours after the last intake, in group 2 the surgery will be scheduled 8 hours after the last intake, while the control group will undergo the procedure with INR values between 2.0 and 3,0. Hemostatic measures with tranexamic acid paste intra alveolar, suture and biological glue GRF® (gelatin, resorcinol and formaldehyde) and post operative care will be associated. The patients will be contacted after the procedure to inform the presence or absence of late bleeding. The patient should return 24 hours later to evaluate the surgical site. This protocol is based on Guidelines and scientific articles, pharmacokinetics and clinical experience of the authors.

Eligibility criteria: Inclusion Criteria:

* Selection of patients: Both genders, aged over 18 years, regardless of ethnicity, marital status, nationality, naturalness or profession, with non-valvular atrial fibrillation using dabigatran or rivaroxaban or apixaban or warfarin, under medical outpatient treatment or during the hospitalization period.
* Dentistry: Patients with indications of exodontia of one to three permanent adjacent teeth erupted in the maxilla or mandible due to extensive dental caries or periodontal disease.

Exclusion Criteria:

* Clinical: Patients on concomitant use of antiplatelet agents or heparin, pregnant and lactating patients, with coagulation disorders, severe chronic renal insufficiency (CrCl \<30), severe hepatopathies and proven to be allergic to lidocaine and / or epinephrine.
* Dentistry: Odontophobic, edentulous, or healthy teeth; Deciduous teeth and Included teeth.
* Regarding the time of medication intake: Regarding the time of medication intake Patients taking rivaroxaban who routinely take the medication between 5:00 a.m. to 4:00 p.m. (unworkable schedule for surgery) that do not accept a change in the intake schedule suggested by the attending physician.

Primary outcomes:
measure: A bleeding event (incidence of postoperative bleeding events)
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Study officials:
affiliation: Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
name: Denise T Hachul, PhD
role: STUDY_DIRECTOR
affiliation: Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
name: Itamara LI Neves, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
name: Elaine M Higashi, S
role: STUDY_CHAIR
affiliation: Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
name: Ricardo S Neves, PhD
role: STUDY_CHAIR
affiliation: Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
name: Francisco CC Darrieux, PhD
role: STUDY_CHAIR
affiliation: Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
name: Mauricio I Scanavacca, PhD
role: STUDY_CHAIR
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