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临床试验/NCT02297971
NCT02297971已完成不适用

Assessment of Coagulation and Thrombocyte Function After Termination of Ticagrelor in Patients Who Have Previously Undergone PCI Procedures and Insertion of Coronary Stents

Örebro University, Sweden1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2013年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
试验地点
1
主要终点
Platelet aggregometry

研究概览

简要总结

When ticagrelor should be discontinued prior to elective surgery is unclear. The risks of bleeding when it is continued peri-operatively have to be weighed against the risk of coronary artery thrombosis when stopped. This study aims to assess coagulation and thrombocyte function every other day in patients who are taking ticagrelor after coronary artery stents and discontinue therapy at the end of one year.

详细描述

Patients who have an acute coronary syndrome are today often treated by percutaneous coronary intervention (PCI) and insertion of one or several coronary stents. Subsequently, these patients are treated with oral anti-platelet (OAP) drugs, usually a combination of acetyl salicylic acid (aspirin) and clopidogrel/ticagrelor. Although aspirin is continued for a life-long period, clopidogrel/ticagrelor are used for a variable period of time, often from 3 months - 1 year after PCI, depending on the type of stent. Interventional elective non-cardiac surgery during the time of clopidogrel/ticagrelor therapy is not recommended except for life-threatening (acute surgery) or life-prolonging (cancer surgery) procedures. Specifically for life-prolonging procedures, surgery can be planned, and therefore the question often arises as to when OAPs should be terminated prior to planned surgery. This decision rests on balancing the risks of bleeding (when continued) or coronary stent thrombosis (when stopped). Certainly, because of the small risk of severe bleeding when using aspirin, this drug should be continued throughout the perioperative period in patients with coronary stents. However, continuing clopidogrel/ticagrelor is more controversial since severe perioperative bleeding is difficult to reverse in these patients. Therefore, surgeons would normally discontinue clopidogrel/ticagrelor prior to surgery, specifically when the potential for bleeding is high, and the consequences major. The exact duration for which these drugs should be discontinued remains unclear and, depending on the drug used, a period of 3 - 5 days is generally recommended, based on the pharmacokinetics and dynamics of clopidogrel/ticagrelor in otherwise healthy patients.

This study was done to better understand coagulation and thrombocyte function immediately before discontinuation of ticagrelor and at regular intervals after termination, in patients who have previously undergone PCI, have coronary stents, are taking ticagrelor but discontinue it after one-year of therapy in accordance with hospital routines. No surgical intervention was planned in these patients after termination of ticagrelor.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
45 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who are on the Cardiology Clinic's database at the University Hospital, Örebro and shall terminate ticagrelor after one year following PCI and stent placement would be identified and offered to take part in this study.

排除标准

  • Non-responders (not partial responders) to ticagrelor would be excluded from the study. Additionally, patients who are either taking NSAID's regularly or during the last 2 weeks prior to study start would also be excluded as those who have language or cognitive limitations.

结局指标

主要结局

Platelet aggregometry

时间窗: 0 - 10 days

Platelet aggregometry using Multiplate assay would be done prior to termination of ticagrelor treatment and thereafter every other day of 10 days.

次要结局

  • Thromboelstography(0-10 days)
  • Coagulation function tests(0-10 days)

研究者

发起方
Örebro University, Sweden
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anil Gupta

Associate Professor

Örebro University, Sweden

研究点 (1)

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