Effect of Continue vs. Stop P2Y12 Inhibitor on Bleeding in Patient Receiving Dual-antiplatelet Therapy Undergoing Dental Procedure.
试验速览
- 阶段
- 4 期
- 入组人数
- 428
- 主要终点
- Incidence of prolong bleeding from dental procedure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The dentist will be blind wheater the patient takes DAPT or not.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years.
- •Need DAPT
- •Need to ybeperform dental procedure such as simple extraction, complex extraction, and also focal, multifocal and total gingival scaling
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Clopidogrel (Drug)
Uninterrupted DAPT
The patient in this arm will continue dual anti platelet until the date of dental procedure.
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Incidence of prolong bleeding from dental procedure
时间窗: immediate after 30 minute post procedure
Observed bleeding at 30 minute after finish dental procedure for 30 minute.
次要结局
- 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.)
研究者
Kultida Lertthanaphol
Cardiology Unit
Chiang Mai University