An observational study in Atrial Fibrillation and Embolism Thrombosis, sponsored by East and North Hertfordshire NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-07.
Sponsored by East and North Hertfordshire NHS Trust · Observational
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.
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 240 is below the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →East and North Hertfordshire NHS Trust is the lead sponsor of 36 studies on the registry; 18 are open to participants now.
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Patients with non-valvular atrial fibrillation. Participants will be recruited via inpatient and outpatient clinical areas.
Exclusion Criteria:
Patients will undergo the global thrombosis test (GTT), thromboelastography (TEG) and thrombin generation assays before and after stabilisation(4 weeks) of their anticoagulation. This will allow to compare the effect of apixaban on endogenous fibrinolysis before and after treatment.
Other: Thrombin generation assays, Thromboelastography (TEG), and Global Thrombosis Test (GTT)
Patients will undergo the global thrombosis test (GTT), thromboelastography (TEG) and thrombin generation assays on stable anticoagulation treatment. This will allow to compare the effect of apixaban against warfarin on endogenous fibrinolysis on stable treatment.
Other: Thrombin generation assays, Thromboelastography (TEG), and Global Thrombosis Test (GTT)
Patients will undergo the global thrombosis test (GTT), thromboelastography (TEG) and thrombin generation assays on stable anticoagulation treatment. This will allow to compare the effect of apixaban against aspirin on endogenous fibrinolysis on stable treatment.
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
Assessing the effect of apixaban on endogenous fibrinolysis in patients wth atrial fibrillation
Measuring endogenous fibrinolysis before and after apixaban
Time frame: Change of endogenous fibrinolysis from baseline at 4 weeks
Comparing the effect of apixaban to warfarin and aspirin on endogenous fibrinolysis in patients with atrial fibrillation
Compare the effect on endogenous fibrinolysis as measured by occlusion time and lysis time (seconds) of stable apixaban, warfarin and aspirin treatment in patients with atrial fibrillation with the GTT,TEG,thrombin generation assays
Time frame: 12 months
Plan to share: Yes
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This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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East and North Hertfordshire NHS Trust