Clinical trial NCT03103685: Continue vs. Stop P2Y12 Inhibitor on Bleeding in Patient Receiving DAPT Undergoing Dental Procedure.
Official title: Effect of Continue vs. Stop P2Y12 Inhibitor on Bleeding in Patient Receiving Dual-antiplatelet Therapy Undergoing Dental Procedure.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dental Diseases
Antiplatelet Agents
Antiplatelet Drugs
Keywords: Dual antiplatelet therapy
Dental procedure
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2017-04-06
Enrollment: 428
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of prolong bleeding from dental procedure
timeFrame: immediate after 30 minute post procedure
Secondary outcomes:
measure: Incidence of severe bleeding
timeFrame: at more than 12 hour after dental procedure or large hepatoma, or ecchymosis, or bleeding that need ER visit.
measure: Incidence of major adverse cardiovascular event (MACE)
timeFrame: 7 and 30 days after dental procedure, patient well be called, to check her/his status.
Other outcomes:
Locations:
Study officials:
affiliation: Chiang Mai University
name: Arintaya Phrommintikul, M.D.
role: STUDY_DIRECTOR
References: