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Search / Trial NCT03181386

Tooth Extraction in Patients With Atrial Fibrillation in Use of New Oral Anticoagulants

Launched by UNIVERSITY OF SAO PAULO GENERAL HOSPITAL · Jun 7, 2017

Trial Information

Current as of May 06, 2025

Completed

Keywords

Dabigatran Rivaroxaban Apixaban Warfarin Tooth Extraction

ClinConnect Summary

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...

Gender

ALL

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.

About University Of Sao Paulo General Hospital

The University of São Paulo General Hospital (Hospital das Clínicas da Universidade de São Paulo) is a leading clinical research institution in Brazil, renowned for its commitment to advancing medical knowledge and patient care. As an academic hospital affiliated with one of the largest and most prestigious universities in Latin America, it integrates clinical practice, education, and research. The hospital conducts a wide array of clinical trials across various medical disciplines, aiming to develop innovative therapies and improve healthcare outcomes. With a multidisciplinary team of healthcare professionals and access to cutting-edge facilities, the University of São Paulo General Hospital is dedicated to fostering scientific advancements and addressing critical health challenges.

Locations

São Paulo, , Brazil

Patients applied

0 patients applied

Trial Officials

Denise T Hachul, PhD

Study Director

Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Itamara LI Neves, PhD

Principal Investigator

Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Elaine M Higashi, S

Study Chair

Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Ricardo S Neves, PhD

Study Chair

Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Francisco CC Darrieux, PhD

Study Chair

Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Mauricio I Scanavacca, PhD

Study Chair

Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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