Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03103685
Recruitment Status : Unknown
Verified March 2017 by Kultida Lertthanaphol, Chiang Mai University.
Recruitment status was:  Not yet recruiting
First Posted : April 6, 2017
Last Update Posted : April 6, 2017
Sponsor:
Information provided by (Responsible Party):
Kultida Lertthanaphol, Chiang Mai University

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.

Condition or disease Intervention/treatment Phase
Dental Diseases Antiplatelet Agents Antiplatelet Drugs Drug: Clopidogrel Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 428 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: The dentist will be blind wheater the patient takes DAPT or not.
Primary Purpose: Treatment
Official Title: Effect of Continue vs. Stop P2Y12 Inhibitor on Bleeding in Patient Receiving Dual-antiplatelet Therapy Undergoing Dental Procedure.
Estimated Study Start Date : May 1, 2017
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Incidence of prolong bleeding from dental procedure [ Time Frame: immediate after 30 minute post procedure ]
    Observed bleeding at 30 minute after finish dental procedure for 30 minute.


Secondary Outcome Measures :
  1. Incidence of severe bleeding [ Time Frame: at more than 12 hour after dental procedure or large hepatoma, or ecchymosis, or bleeding that need ER visit. ]
    Observed severe bleeding at subacute to late phase after dental procedure.

  2. Incidence of major adverse cardiovascular event (MACE) [ Time Frame: 7 and 30 days after dental procedure, patient well be called, to check her/his status. ]
    montior MACE after stop P2Y12



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03103685


Contacts
Layout table for location contacts
Contact: Kultida Lertthanaphol, M.D. 053936713 k.lertthanaphol@gmail.com
Contact: Krit Leemasawat, M.D. 053936713 krit_lee@yahoo.com

Sponsors and Collaborators
Chiang Mai University
Investigators
Layout table for investigator information
Study Director: Arintaya Phrommintikul, M.D. Chiang Mai University
Layout table for additonal information
Responsible Party: Kultida Lertthanaphol, Cardiology Unit, Chiang Mai University
ClinicalTrials.gov Identifier: NCT03103685    
Other Study ID Numbers: MED-2559-04408
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: April 6, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by Kultida Lertthanaphol, Chiang Mai University:
Dual antiplatelet therapy
Dental procedure
Additional relevant MeSH terms:
Layout table for MeSH terms
Stomatognathic Diseases
Clopidogrel
Ticagrelor
Prasugrel Hydrochloride
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs