Continue vs. Stop P2Y12 Inhibitor on Bleeding in Patient Receiving DAPT Undergoing Dental Procedure.

Dental Diseases Clinical Trial

Official title:

Effect of Continue vs. Stop P2Y12 Inhibitor on Bleeding in Patient Receiving Dual-antiplatelet Therapy Undergoing Dental Procedure.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03103685
• Other study ID #: MED-2559-04408
• Status: Not yet recruiting
• Phase: Phase 4
• First received: March 31, 2017
• Last updated: March 31, 2017
• Start date: May 1, 2017
• Est. completion date: December 30, 2018

Study information

• Verified date: March 2017
• Source: Chiang Mai University
• Contact: Kultida Lertthanaphol, M.D.
• Phone: 053936713
• Email: k.lertthanaphol[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective randomized open-label blinded endpoint (PROBE) The study will be conducted in Maharaj Nakorn Chiang Mai hospital. The patients with dual-antipletlet who need dental procedure between Febuary 2017 until Febuary 2018 will be included in the study. Baseline characteristics of the enrolled patients including bleeding complication will be collected in each patient. To compare rate of significant bleeding from dental procedure between patient who need two antiplatelet and who stop P2Y12 inhibitors before procedure.

Description:

Treatment of coronary artery disease is re-open the occluded artery by many ways such as removed clot and coronary stenting. Which needed two antiplatelet after the procedure at least a month to a year. Some patient must have life long period to prevent the stent occlude and stenosis. But dental problem is commonly found in real life practice. Many people suffered from toothache and have to wait until a year, just to prevent bleeding. Physicians often be consulted with this dilemma. To continue there are some risk to bleed but discontinue antipletlet can cause recurrent myocardial ischemia. Which the highest risk factor of stent thrombosis is early stop anti platelet. Since there is no clinical practice guideline in Thailand, this study is to compare rate of dental bleeding between patient who continue two antoplatelet and who stop only P2Y12 inhibitor. The study include immediate bleeding, 24 hour and a week after procedure, follow up for major cardiovascular event such as myocardial ischemia, stroke and death. In order to create further clinical practice for this specific group.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 428
• Est. completion date: December 30, 2018
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >18 years.

• Need DAPT

• Need to ybeperform dental procedure such as simple extraction, complex extraction, and also focal, multifocal and total gingival scaling

Exclusion Criteria:

• patient with coagulopathy

• patient with Hemophilia

• patient with cirrhosis and renal pailure( BUN > 60, Cr > 6.0)

• patient who unable to come for medical visit in emergency condition such as severe bleeding

• patient with severe disease eg. advance stage cancer.

• patient with history of ACS less than 6 month

• patient who was be PCI wit DESless than 6 month

• patient with DAPT but planned to be CABG within a year.

• patient with anticoagulant

• patient who've got bisphosphonate within 2 years

Related Conditions & MeSH terms

• Antiplatelet Agents
• Antiplatelet Drugs
• Dental Diseases
• Stomatognathic Diseases

Intervention

Drug:
• Clopidogrel
The patient s in experimental arm will not be ask to stop P2Y12 inhibitor such as Clopidogrel, Prasugrel or Ticagrelor

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of prolong bleeding from dental procedure	Observed bleeding at 30 minute after finish dental procedure for 30 minute.	immediate after 30 minute post procedure
Secondary	Incidence of severe bleeding	Observed severe bleeding at subacute to late phase after dental procedure.	at more than 12 hour after dental procedure or large hepatoma, or ecchymosis, or bleeding that need ER visit.
Secondary	Incidence of major adverse cardiovascular event (MACE)	montior MACE after stop P2Y12	7 and 30 days after dental procedure, patient well be called, to check her/his status.