RecruitingNCT06124612

An Investigator-initiated Linked Study to OCEANIC-AF

Assessing the Effect of Asundexian on Thrombotic Status, in Particular Endogenous Fibrinolysis, in Patients With Atrial Fibrillation

Sponsor

East and North Hertfordshire NHS Trust

Enrollment

100 participants

Start Date

Nov 3, 2023

Study Type

OBSERVATIONAL

Conditions

Atrial Fibrillation

Summary

Impaired endogenous fibrinolysis is a recently recognised risk factor for thrombotic events in patients with cardiovascular disease. Enhancing endogenous fibrinolysis in such individuals represents a way of reducing thrombosis risk. However, the optimal pharmacotherapy to enhance fibrinolysis is unclear. The aim of this study is to assess the effect of asundexian on endogenous fibrinolysis and compare this to apixaban. If asundexian can enhance endogenous fibrinolysis, this could be used as targeted treatment for patients who despite optimal antithrombotic therapy, demonstrate impaired endogenous fibrinolysis.

Eligibility

Min Age: 18 Years

Inclusion Criteria2

Patients aged 18 years or over
Patients enrolled in OCEANIC-AF study

Exclusion Criteria9

The patient is willing and able to understand the Patient Information Sheet and provide written informed consent
The patient agrees to comply with the drawing of blood samples for the assessments.
Inability to provide valid informed consent
Patients aged \< 18 years of age
Patients with significant neurological, hepatic, renal, endocrine, gastrointestinal, pulmonary, haemorrhagic, metabolic or other disease likely to confound the study requirements or analyses
Patients with a history of substance abuse or signs or clinical features of active substance abuse or psychiatric disease
Alcohol consumption above 21 units per week
Any illness deemed significant by the investigator during the four (4) weeks preceding the screening period of the study
Any major bleeding diathesis or blood dyscrasia (platelets \<70 x 109/l, Hb \<80 g/dl, INR \>1.4, APTT \>x 2 UNL, leucocyte count \<3.5 x 109/l, neutrophil count \<1 x 109/l)

Interventions

DIAGNOSTIC_TESTThrombotic assessment

GTT The Global Thrombosis Test (GTT) (Thromboquest Limited, UK) is an in vitro method imitating high shear stress conditions akin to that which exist in a severely stenosed artery. The test measures platelet reactivity (occlusion time) and endogenous fibrinolysis time (lysis time). TEG Thromboelastography (TEG, Haemonetics Corporation, USA) is a technique that assesses the whole process of clotting and its viscoelastic properties, from the initial activation and aggregation of platelets, to the role of thrombin and finally the stability of the formed clot, as a measure of fibrinolytic resistance. Citrated plasma will be stored for subsequent evaluation of thrombosis and fibrinolysis markers (including but not restricted to D-dimer, PAI-1, hs-CRP, NETs)