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
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Periodontal Disease Hemorrhage||Drug: Rivaroxaban Drug: Dabigatran and Apixaban Drug: Warfarin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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|
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.
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.
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
- 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.
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
|Contact: Itamara LI Neves, PhDfirstname.lastname@example.org|
|Contact: Elaine M Higashi, Semail@example.com|
|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 firstname.lastname@example.org|
|Contact: Itamara LI Neves, PhD 55-1126614142 email@example.com|
|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|