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

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ClinicalTrials.gov Identifier: NCT03181386
Recruitment Status : Recruiting
First Posted : June 8, 2017
Last Update Posted : June 8, 2017
Sponsor:
Information provided by (Responsible Party):
Itamara Lucia Itagiba Neves, University of Sao Paulo General Hospital

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Periodontal Disease Hemorrhage Drug: Rivaroxaban Drug: Dabigatran and Apixaban Drug: Warfarin Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : May 3, 2017
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : April 30, 2021


Arm Intervention/treatment
Experimental: Rivaroxaban
As the rivaroxaban is ingested 1x/day, the interval between a maximum peak concentration and the other peak is 24 hours. Therefore, the surgery will be performed between two peaks of maximum drug concentration, knowing that the maximum peak concentration is an average of two hours after ingestion. So the surgical procedure should be scheduled 14 hours (2 hours+ 12 hours) after the last medication intake.
Drug: Rivaroxaban
Rivaroxaban 15 or 20mg tablet by mouth, every 24 hours, continuous use.
Other Name: Xarelto

Experimental: Dabigatran and Apixaban
As dabigatran and apixaban are taken 2x/day, the interval between two peak concentration is 12 hours.Taking into account the first two hours of maximum peak concentration and half the interval between two peaks (2 hours + 6 hours = 8 hours), the surgical procedure must be programmed eight hours after the last intake of medication.
Drug: Dabigatran and Apixaban
Dabigatrana 110 or 150 mg tablet and Apixaban 2,5 or 5mg tablet by mouth, every 12 hours, continuous use.
Other Name: Pradaxa and Eliquis

Active Comparator: Warfarin
The control group will consist of patients on chronic use of warfarin. The operation will be scheduled at any time, provided that the patient has INR value between 2.0 and 3.0 and test performed in maximum 15 days before surgery.
Drug: Warfarin
The dosage of Warfarin is individualized for each patient, according to the patient's TP/INR value. The value of TP/INR should be in the therapeutic dosage of 2.0 to 3.0
Other Name: Marevan




Primary Outcome Measures :
  1. A bleeding event (incidence of postoperative bleeding events) [ Time Frame: 7 days ]
    To evaluate the safety of a protocol regarding the risks of bleeding after dental extractions performed in patients with non-valvular atrial fibrillation in continuous use of the new oral anticoagulants, we compared the incidence of postoperative bleeding events after dental extractions between patients in use of new oral anticoagulants and those treated of warfarin without withdrawal of oral anticoagulant therapy.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03181386


Contacts
Contact: Itamara LI Neves, PhD 55-11-26615229 itamara.neves@incor.usp.br
Contact: Elaine M Higashi, S 55-11-981098642 elaine_mh@hotmail.com

Locations
Brazil
Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo Recruiting
São Paulo, Brazil, 05403000
Contact: Elaine M Higashi, S    55-1126614142    elaine_mh@hotmail.com   
Contact: Itamara LI Neves, PhD    55-1126614142    itamara.neves@incor.usp.br   
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Study Director: Denise T Hachul, PhD Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Principal Investigator: Itamara LI Neves, PhD Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Study Chair: Elaine M Higashi, S Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Study Chair: Ricardo S Neves, PhD Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Study Chair: Francisco CC Darrieux, PhD Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Study Chair: Mauricio I Scanavacca, PhD Heart Institute of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Publications:

Responsible Party: Itamara Lucia Itagiba Neves, PhD, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT03181386     History of Changes
Other Study ID Numbers: Odonto-NOAC
First Posted: June 8, 2017    Key Record Dates
Last Update Posted: June 8, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After thesis defense, the IPD will be available on the Portal Digital Library of Theses and Dissertations of the University of São Paulo (http://www.teses.usp.br/index.php?option=com_jumi&fileid=12&Itemid=77&lang=ptbr), in a PDF file.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Itamara Lucia Itagiba Neves, University of Sao Paulo General Hospital:
Dabigatran
Rivaroxaban
Apixaban
Warfarin
Tooth Extraction

Additional relevant MeSH terms:
Periodontal Diseases
Gingival Diseases
Heart Diseases
Cardiovascular Diseases
Mouth Diseases
Stomatognathic Diseases
Atrial Fibrillation
Hemorrhage
Arrhythmias, Cardiac
Pathologic Processes
Apixaban
Warfarin
Rivaroxaban
Anticoagulants
Dabigatran
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action