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

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

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.

Study Overview

• Status: Unknown
• Conditions: Antiplatelet Agents; Dental Diseases; Antiplatelet Drugs
• Intervention / Treatment: Drug: Clopidogrel

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 428
• Phase: Phase 4

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: ASA alone; The patient in this arm will be ask to stop P2Y12 inhibitor before dental procedure, 5 days for clopidogrel and ticagrelol and 7 days for prasugrel.	Drug: Clopidogrel; The patient s in experimental arm will not be ask to stop P2Y12 inhibitor such as Clopidogrel, Prasugrel or Ticagrelor; Other Names: Prasugrel; Ticagrelor
EXPERIMENTAL: Uninterrupted DAPT; The patient in this arm will continue dual anti platelet until the date of dental procedure.	Drug: Clopidogrel; The patient s in experimental arm will not be ask to stop P2Y12 inhibitor such as Clopidogrel, Prasugrel or Ticagrelor; Other Names: Prasugrel; Ticagrelor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Chiang Mai University
• Investigators: Study Director: Arintaya Phrommintikul, M.D., Chiang Mai University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2017
• Primary Completion (ANTICIPATED): December 30, 2018
• Study Completion (ANTICIPATED): December 30, 2018

Study Registration Dates

• First Submitted: March 31, 2017
• First Submitted That Met QC Criteria: March 31, 2017
• First Posted (ACTUAL): April 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2017
• Last Update Submitted That Met QC Criteria: March 31, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Dual antiplatelet therapy; Dental procedure
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Ticagrelor; Clopidogrel; Prasugrel Hydrochloride
• Other Study ID Numbers: MED-2559-04408

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes