Dental DiseasesPhase 4NCT03103685
Continue vs. Stop P2Y12 Inhibitor on Bleeding in Patient Receiving DAPT Undergoing Dental Procedure.
A Phase 4 study testing Clopidogrel in people with Dental Diseases and Antiplatelet Agents, run by Chiang Mai University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Diseases, Antiplatelet Agents, Antiplatelet Drugs
- What is being tested?
- Clopidogrel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 428 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2017to 30 Dec 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years.
- Need DAPT
- Need to ybeperform dental procedure such as simple extraction, complex extraction, and also focal, multifocal and total gingival scaling
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Continue vs. Stop P2Y12 Inhibitor on Bleeding in Patient Receiving Dual-antiplatelet Therapy Undergoing Dental Procedure.
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.
Read the 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
- Being tested
- Clopidogrel
- Keywords
- Dual antiplatelet therapy, Dental procedure
- Medical subject headings
- Stomatognathic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClopidogrelDrug
Also called Prasugrel, Ticagrelor
The patient s in experimental arm will not be ask to stop P2Y12 inhibitor such as Clopidogrel, Prasugrel or Ticagrelor
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Clopidogrel |
| Uninterrupted DAPT | Experimental | The patient in this arm will continue dual anti platelet until the date of dental procedure. Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of prolong bleeding from dental procedure
Observed bleeding at 30 minute after finish dental procedure for 30 minute.
Measured: immediate after 30 minute post procedure
Secondary outcomes (2)
Incidence of severe bleeding
Observed severe bleeding at subacute to late phase after dental procedure.
Measured: 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)
montior MACE after stop P2Y12
Measured: 7 and 30 days after dental procedure, patient well be called, to check her/his status.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start1 May 2017 (estimated)
- Primary completion30 Dec 2018 (estimated)
- Study completion30 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 428 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kultida Lertthanaphol, Chiang Mai University
- Investigators
- Arintaya Phrommintikul, M.D., Study director, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03103685
- Sponsor's protocol ID
- MED-2559-04408
- Status last verified
- Mar 2017
- First submitted
- 31 Mar 2017
- Last updated
- 6 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Continue vs. Stop P2Y12 Inhibitor on Bleeding in Patient Receiving Dual-antiplatelet Therapy Undergoing Dental Procedure.
- ClinicalTrials.gov ID
- NCT03103685
- Acronym / sponsor ID
- MED-2559-04408
- Conditions
- Dental Diseases, Antiplatelet Agents, Antiplatelet Drugs
- Keywords
- Dual antiplatelet therapy, Dental procedure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 428 participants (estimated)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (estimated)
- Primary completion
- 30 Dec 2018 (estimated)
- Study completion
- 30 Dec 2018 (estimated)
- First posted
- 6 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASA alone | Placebo comparator | Drug: ClopidogrelThe 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. |
| Uninterrupted DAPT | Experimental | Drug: ClopidogrelThe patient in this arm will continue dual anti platelet until the date of dental procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 years.
- Need DAPT
- Need to ybeperform dental procedure such as simple extraction, complex extraction, and also focal, multifocal and total gingival scaling
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClopidogrelAlso: Prasugrel, TicagrelorThe patient s in experimental arm will not be ask to stop P2Y12 inhibitor such as Clopidogrel, Prasugrel or Ticagrelor | Drug | ASA alone, Uninterrupted DAPT |
Primary outcome
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.
2 secondary outcomes
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arintaya Phrommintikul, M.D. study director
Chiang Mai University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clopidogrel in people with Dental Diseases and Antiplatelet Agents, run by Chiang Mai University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kultida Lertthanaphol, M.D. (053936713, k.lertthanaphol@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of prolong bleeding from dental procedure (time frame: immediate after 30 minute post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2017.