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

NCT03103685 | Unknown Phase 4 FDA Drug

• 1 other identifier: MED-2559-04408
• Study Type: interventional
• Target: 428
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dental Diseases; Antiplatelet Agents; Antiplatelet Drugs

Keywords

Dual antiplatelet therapy; Dental procedure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence of severe bleeding

  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)

  7 and 30 days after dental procedure, patient well be called, to check her/his status.

Study Arms (2)

ASA alone

PLACEBO COMPARATOR

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

Uninterrupted DAPT

EXPERIMENTAL

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

Drug: Clopidogrel

Interventions

Clopidogrel DRUG

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

Also known as: Prasugrel, Ticagrelor

ASA alone; Uninterrupted DAPT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years.
• Need DAPT
• Need to ybeperform dental procedure such as simple extraction, complex extraction, and also focal, multifocal and total gingival scaling

You may not qualify if:

• 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

Sponsors & Collaborators

• Chiang Mai University: lead

MeSH Terms

Conditions

Stomatognathic Diseases

Interventions

Clopidogrel; Prasugrel Hydrochloride; Ticagrelor

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Piperazines; Adenosine; Purine Nucleosides; Purines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Arintaya Phrommintikul, M.D.

  Chiang Mai University

  STUDY DIRECTOR

Central Study Contacts

Kultida Lertthanaphol, M.D.

CONTACT

053936713; k.lertthanaphol@gmail.com

Krit Leemasawat, M.D.

CONTACT

053936713; krit_lee@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The dentist will be blind wheater the patient takes DAPT or not.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiology Unit

Study Record Dates

• First Submitted: March 31, 2017
• First Posted: April 6, 2017
• Study Start: May 1, 2017
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2018
• Last Updated: April 6, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share