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

NCT03181386 | Completed Phase 3 DMC

• 1 other identifier: Odonto-NOAC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Periodontal Disease; Hemorrhage

Keywords

Dabigatran; Rivaroxaban; Apixaban; Warfarin; Tooth Extraction

Outcome Measures

Primary Outcomes (1)

• A bleeding event (incidence of postoperative bleeding events)

  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.

  7 days

Study Arms (3)

Rivaroxaban

EXPERIMENTAL

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

Dabigatran and Apixaban

EXPERIMENTAL

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

Warfarin

ACTIVE COMPARATOR

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

Interventions

Rivaroxaban DRUG

Rivaroxaban 15 or 20mg tablet by mouth, every 24 hours, continuous use.

Also known as: Xarelto

Rivaroxaban

Dabigatran and Apixaban DRUG

Dabigatrana 110 or 150 mg tablet and Apixaban 2,5 or 5mg tablet by mouth, every 12 hours, continuous use.

Also known as: Pradaxa and Eliquis

Dabigatran and Apixaban

Warfarin DRUG

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

Also known as: Marevan

Warfarin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

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

São Paulo, 05403000, Brazil

Location

Related Publications (24)

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MeSH Terms

Conditions

Atrial Fibrillation; Periodontal Diseases; Hemorrhage

Interventions

Rivaroxaban; Dabigatran; apixaban; Warfarin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans

Study Officials

• Denise T Hachul, PhD

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

  STUDY DIRECTOR

• Itamara LI Neves, PhD

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

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 2, 2017
• First Posted: June 8, 2017
• Study Start: May 3, 2017
• Primary Completion: November 30, 2020
• Study Completion: February 1, 2022
• Last Updated: June 15, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)