CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 60 enrolled
Drug / intervention
Rivaroxaban +2 moredrug
Likely dose
Rivaroxaban 20mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03181386
NCT03181386Phase 3Completed
CompareCT.gov

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

University of Sao Paulo General Hospital·interventional·Posted Jun 8, 2017·Updated Jun 15, 2022

In Brief

A Phase 3 clinical trial evaluating Rivaroxaban, Dabigatran and Apixaban, and 1 other intervention for Atrial Fibrillation and 2 related conditions. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation, Periodontal Disease, Hemorrhage
CountriesBrazil
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJun 8, 2017
Enrollment StartMay 3, 2017
Primary CompletionNov 30, 2020
Study CompletionFeb 1, 2022
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 9.1 years ago

Interventions

Rivaroxabandrug

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

Dabigatran and Apixabandrug

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

Warfarindrug

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