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
About this trial
This is an interventional treatment trial for Dental Diseases focused on measuring Dual antiplatelet therapy, Dental procedure
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
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
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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Continue vs. Stop P2Y12 Inhibitor on Bleeding in Patient Receiving DAPT Undergoing Dental Procedure.
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