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

Primary Purpose

Dental Diseases, Antiplatelet Agents, Antiplatelet Drugs

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Clopidogrel
Sponsored by
Chiang Mai University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Diseases focused on measuring Dual antiplatelet therapy, Dental procedure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    ASA alone

    Uninterrupted DAPT

    Arm 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.

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

    Outcomes

    Primary Outcome Measures

    Incidence of prolong bleeding from dental procedure
    Observed bleeding at 30 minute after finish dental procedure for 30 minute.

    Secondary Outcome Measures

    Incidence of severe bleeding
    Observed severe bleeding at subacute to late phase after dental procedure.
    Incidence of major adverse cardiovascular event (MACE)
    montior MACE after stop P2Y12

    Full Information

    First Posted
    March 31, 2017
    Last Updated
    March 31, 2017
    Sponsor
    Chiang Mai University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03103685
    Brief Title
    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

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 1, 2017 (Anticipated)
    Primary Completion Date
    December 30, 2018 (Anticipated)
    Study Completion Date
    December 30, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chiang Mai University

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Diseases, Antiplatelet Agents, Antiplatelet Drugs
    Keywords
    Dual antiplatelet therapy, Dental procedure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Masking Description
    The dentist will be blind wheater the patient takes DAPT or not.
    Allocation
    Randomized
    Enrollment
    428 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ASA alone
    Arm Type
    Placebo Comparator
    Arm 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.
    Arm Title
    Uninterrupted DAPT
    Arm Type
    Experimental
    Arm Description
    The patient in this arm will continue dual anti platelet until the date of dental procedure.
    Intervention Type
    Drug
    Intervention Name(s)
    Clopidogrel
    Other Intervention Name(s)
    Prasugrel, Ticagrelor
    Intervention Description
    The patient s in experimental arm will not be ask to stop P2Y12 inhibitor such as Clopidogrel, Prasugrel or Ticagrelor
    Primary Outcome Measure Information:
    Title
    Incidence of prolong bleeding from dental procedure
    Description
    Observed bleeding at 30 minute after finish dental procedure for 30 minute.
    Time Frame
    immediate after 30 minute post procedure
    Secondary Outcome Measure Information:
    Title
    Incidence of severe bleeding
    Description
    Observed severe bleeding at subacute to late phase after dental procedure.
    Time Frame
    at more than 12 hour after dental procedure or large hepatoma, or ecchymosis, or bleeding that need ER visit.
    Title
    Incidence of major adverse cardiovascular event (MACE)
    Description
    montior MACE after stop P2Y12
    Time Frame
    7 and 30 days after dental procedure, patient well be called, to check her/his status.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kultida Lertthanaphol, M.D.
    Phone
    053936713
    Email
    k.lertthanaphol@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Krit Leemasawat, M.D.
    Phone
    053936713
    Email
    krit_lee@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Arintaya Phrommintikul, M.D.
    Organizational Affiliation
    Chiang Mai University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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