NCT03199521

Assessment of The Effect of Apixaban in AF

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 240 (actual)
• Sponsor: East and North Hertfordshire NHS Trust · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Atrial Fibrillation
• Embolism Thrombosis

Interventions

Type	Name	Description
OTHER	Thrombin generation assays, Thromboelastography (TEG), and Global Thrombosis Test (GTT)	Global Thrombosis Test (GTT): assesses formation of the blood clot and how easily can this be broken down once formed) Thromboelastography (TEG) :assesses the properties of a blood clot and how easily can be broken down Thrombin generation assays: assesses the formation of a blood clot and the potential of thrombolysis via the introduction of different buffer solutions

Timeline

• Start date: 2017-06-01
• Primary completion: 2019-01-02
• Completion: 2019-01-02
• First posted: 2017-06-27
• Last updated: 2019-02-07

Locations

1 site across 1 country: United Kingdom