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临床试验/NCT05195372
NCT05195372已完成不适用

The APSANTICO-registry - Evaluation of the Efficacy and Safety of Different Anticoagulants in Patients With Thromboembolic Antiphospholipid Syndrome (APS)

Cardioangiologisches Centrum Bethanien1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Recurrent thromboembolism despite coagulation inhibition

研究概览

简要总结

Retrospective monocentric registry to evaluate the efficacy and safety of different anticoagulants in patients with thromboembolic antiphospholipid syndrome

详细描述

Antiphospholipid syndrome is a thrombophilic diathesis characterised by the occurrence of recurrent, unprovoked thromboembolic events (arterial, venous, microvascular) in combination with the presence of specific APS antibodies.

A distinction is made between different subtypes of APS. One is the thrombotic antiphospholipid syndrome (APS), which is the focus of the registry, and the other is obstetric APS, which is characterised by obstetric complications.

The particular challenge in dealing with APS patients is to establish an adequate therapy regime, as some patients suffer from an increased risk of recurrent thrombosis despite anticoagulation and/or aggregation inhibition.

The standard medication for antiphospholipid syndrome is based on the use of vitamin K antagonists (VKA). This regimen is essential to follow, especially in high-risk patients with positive lupus anticoagulants and/or triple positive antiphospholipid antibodies.

In 2019, a 'Red Hand Letter' was issued advising against treating APS patients with direct oral anticoagulants (DOACs) but so far some studies suggest that alternative anticoagulation with DOACs may be beneficial in a selected patient population with a single- or double-positive antiphospholipid antibody profile.

研究设计

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

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Minimum age of 18 years
  • Confirmed antiphospholipid syndrome with thromboembolic clinical manifestations (VTE, LAE, stroke etc.)
  • Patients with APS antibody risk profile (single/double/triple positivity)

排除标准

  • APS with isolated pregnancy complications
  • No coagulation inhibition
  • Inadequately diagnosed APS
  • Non-compliance of patients

结局指标

主要结局

Recurrent thromboembolism despite coagulation inhibition

时间窗: 2015 - 2021

The main observational variable is the occurrence of recurrent thromboembolic events under DOAC-treatment compared to VKA-treatment and/or other therapeutic regimens (e.g. low molecular weight heparins, aggregation inhibitors) in patients with different APS risk profiles.

次要结局

  • major bleeding during coagulation inhibition(2015 - 2021)

研究者

发起方
Cardioangiologisches Centrum Bethanien
申办方类型
Other
责任方
Sponsor

研究点 (1)

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