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

Chiang Mai University

Status and phase: Unknown; Phase 4

Conditions: Antiplatelet Agents; Antiplatelet Drugs; Dental Diseases

Treatments: Drug: Clopidogrel

Study type: Interventional

Funder types: Other

Identifiers

NCT03103685

MED-2559-04408

Details and patient eligibility

About

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.

Full 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.

Enrollment: 428 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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428 participants in 2 patient groups, including a placebo group

ASA alone

Placebo Comparator group

Description:

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.

Treatment:

Drug: Clopidogrel

Uninterrupted DAPT

Experimental group

Description:

The patient in this arm will continue dual anti platelet until the date of dental procedure.

Treatment:

Drug: Clopidogrel