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临床试验/NCT03199521
NCT03199521已完成不适用

Assessing The Effect of Apixaban on Endogenous Fibrinolysis in Patients With Non-Valvular Atrial Fibrillation

East and North Hertfordshire NHS Trust1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2017年6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
240
试验地点
1
主要终点
Assessing the effect of apixaban on endogenous fibrinolysis in patients wth atrial fibrillation

研究概览

简要总结

This study will assess the effect of apixaban on thrombotic status in patients with atrial fibrillation.In addition it will compare apixaban to aspirin and warfarin on their effect on endogenous fibrinolysis.

详细描述

Patients with an irregular heart rhythm called atrial fibrillation (AF) have an increased risk of forming blood clots inside the heart, that can then fragment and break off, travelling through the circulation to the brain, where it can cause blockage of the small blood vessels resulting in a stroke. Most patients with AF are prescribed blood thinning medications in an attempt to prevent such clot formation. The body has the ability through enzymes circulating in blood, to dissolve a clot once formed, such that even if a clot is formed, it is rapidly dissolved and no lasting damage is sustained. This is known as endogenous fibrinolysis. If this defence system is faulty or suboptimal, there is an increased risk of clot formation, resulting in stroke or heart attack. Currently, there are no available tablets to favourably modify this defence system of endogenous fibrinolysis. The investigators will assess how this defence system functions in patients with AF who are on different blood thinners. Then the investigators will also assess a group of patients before and during treatment with a relatively new blood thinner called apixaban, to assess the effect of this on the stickiness of blood and the ability of the blood to dissolve clots (endogenous fibrinolysis). All the blood thinners will be prescribed for clinical indications, not as part of the research. The research aspect of the study is that we will perform a blood test to assess endogenous fibrinolysis.

Understanding the effect of apixaban on endogenous fibrinolysis raises the possibility that apixaban, rather than other blood thinners, may be of particular use in patients with impaired fibrinolysis who are at particularly high risk of clots due to inefficient endogenous fibrinolysis.

研究设计

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

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

  • Age >18 years
  • Diagnosis of NVAF (nonvalvular atrial fibrillation)
  • Requiring anticoagulation or antiplatelet therapy for thromboprophylaxis of stroke and systemic embolism
  • No contra-indications to apixaban (except for those patients taking part in baseline cross-sectional study where this inclusion criterion does not apply)
  • Patient does not meet any of the exclusion criteria below

排除标准

  • Patient unwilling or unable to give informed consent
  • Patient already taking antiplatelet or anticoagulant therapy (except for those patients taking part in baseline cross-sectional study, where this exclusion criterion does not apply)
  • Patient who, in the opinion of the investigator, has significant hepatic or renal impairment likely to cause a bleeding diathesis
  • Patient needing systemic high dose steroids or immunosuppression that may impact on platelet function
  • Patient with ongoing active alcohol or substance abuse or demonstrates signs or clinical features of active substance abuse
  • Patient with any major bleeding diathesis or blood dyscrasia at baseline (platelets<70 x 109/l, Hb<80 g/l, INR >1.4 (international normalized ratio), APTT (activated partial thromboplastin time ) > x 2UNL (upper normal limit) , leucocyte count< 3.5x 109/l, neutrophil count<1x 109/l).
  • Patient currently involved in another investigational trial of a medicine or medical device

结局指标

主要结局

Assessing the effect of apixaban on endogenous fibrinolysis in patients wth atrial fibrillation

时间窗: Change of endogenous fibrinolysis from baseline at 4 weeks

Measuring endogenous fibrinolysis before and after apixaban

次要结局

  • Comparing the effect of apixaban to warfarin and aspirin on endogenous fibrinolysis in patients with atrial fibrillation(12 months)

研究者

发起方
East and North Hertfordshire NHS Trust
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Prof Diana Gorog

Professor,University of Hertfordshire

East and North Hertfordshire NHS Trust

研究点 (1)

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