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

NCT ID: NCT03103685

Last Updated: 2017-04-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 428 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2018-12-30

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.

Conditions

Dental Diseases; Antiplatelet Agents; Antiplatelet Drugs

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Clopidogrel

Intervention Type: DRUG

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

Uninterrupted DAPT

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

Group Type: EXPERIMENTAL

Clopidogrel

Intervention Type: DRUG

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

Interventions

Clopidogrel

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

Intervention Type: DRUG

Other Intervention Names

Prasugrel; Ticagrelor

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chiang Mai University

OTHER

Sponsor Role: lead

Responsible Party

Kultida Lertthanaphol

Cardiology Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arintaya Phrommintikul, M.D.

Role: STUDY_DIRECTOR

Chiang Mai University

Central Contacts

Kultida Lertthanaphol, M.D.

Role: CONTACT

k.lertthanaphol@gmail.com

053936713

Krit Leemasawat, M.D.

Role: CONTACT

krit_lee@yahoo.com

053936713

Other Identifiers

MED-2559-04408

Identifier Type: -

Identifier Source: org_study_id