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临床试验/NCT05028777
NCT05028777招募中不适用

Cohort of Patients With Left Ventricular Thrombus: Management and Outcomes in the Direct Oral Anticoagulants Era

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 550 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
550
试验地点
1
主要终点
The occurrence at 1 year of bleeding

研究概览

简要总结

The investigators' primary objective is to assess whether a difference in the occurrence of bleeding events exist between patients with LVT treated with DOACs as compared to those treated with VKAs.

详细描述

Left ventricular thrombus (LVT) is a well-known complication of left ventricle (LV) systolic dysfunction that can be seen in acute systolic dysfunction, i.e. induced by an acute myocardial infarction (AMI) or Takotsubo cardiomyopathy, and in chronic heart failure with reduced ejection fraction (HFrEF), whatever the cause.

Improvements in the management of AMI, particularly with the implementation of primary percutaneous coronary intervention (PCI), have led to a striking reduction in the occurrence of LVT in patients with AMI from about 30% in the thrombolytic era to about 4% nowadays, according to echocardiographic assessment. On the other hand prognosis of patients with LVT didn't change over time: mortality and risk of embolic events associated with this condition are still high.

A limited amount of evidence shows that oral anticoagulation is associated in the majority of patients with both resolution of LVT and reduction in ischemic events. This benefit comes at the cost of bleeding complications, which have been demonstrated to impact on mortality, especially in patients after AMI receiving an oral anticoagulant on top of a dual antiplatelet therapy (so-called triple antithrombotic therapy).

Current European and American guidelines on treatment of myocardial infarction with ST-elevation do not make strong recommendations for the management of LVT, whereas guidelines on treatment of heart failure do not give any. The European Society of Cardiology recommends an anticoagulation treatment for up to 6 months from diagnosis in case of LVT thrombus after AMI and the decision to continue the therapy after 6 months should be taken on the basis of echocardiographic follow-up (class IIa level of evidence C). The American College of Cardiology and American Heart Association (AHA) gives a similar recommendation (IIaC), however specifically mentioning vitamin K antagonists (VKAs) and a target INR (international normalized ratio) 2.0-2.5 for 3 months on top of dual antiplatelet therapy (DAPT). They also propose to consider an anticoagulant therapy for patients with severe anterior wall motion after STEMI but without LVT (IIbC). The AHA and American Stroke Association published in 2014 their last recommendations for secondary stroke prevention, which are in line with the above mentioned guidelines. Direct oral anticoagulants (DOACs) are mentioned as an alternative to VKAs (IIbC).

All guidelines agree that DOACs for LVT treatment cannot be recommended as first-line therapy because of the scarce evidence, based on case reports small case series and only one large retrospective study (RED VELVT study, published on April 22, 2020).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

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

入选标准

  • Patients at least 18 years old at enrolment
  • With a LVT identified at echocardiography, MRI or CT between January 1st, 2013 and July 31st, 2020
  • Treated at least once at the Inselspital or in another site of the Insel Gruppe
  • Able to provide a written informed consent

排除标准

  • Documented refusal

结局指标

主要结局

The occurrence at 1 year of bleeding

时间窗: 1 year

Primary combined endpoint includes the occurrence at 1 year of bleeding BARC (Bleeding Academic Research) Consortium type 2, 3 or 5.

次要结局

  • Rate of patients with myocardial infraction(1, 2 and 5 years)
  • Rate of patients with ischemic stroke(1, 2 and 5 years)
  • Rate of patients with arterial systemic embolic event(1, 2 and 5 years)
  • All-cause mortality(1, 2 and 5 years)
  • LVT size/resolution(5 years)
  • Rate of patients with peripheral embolism(1, 2 and 5 years)
  • Rate of patients with transient ischemic attack(1, 2 and 5 years)
  • Rate of patients with pulmonary embolism(1, 2 and 5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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