An Investigator-initiated Linked Study to OCEANIC-AF

ConditionAtrial Fibrillation

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorEast and North Hertfordshire NHS Trust

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18 years or over

Patients enrolled in OCEANIC-AF study

Free from the

Disqualifiers

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

Trial population

All patients enrolled into OCEANIC-AF study at these two centres will be approached to also participate in this linked study.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Thrombotic assessment
Diagnostic test
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)

Treatment groups

100 Participants

are divided into 1 treatment group

Group A: Atrial fibrillation1 intervention

Trial outcomes

Primary outcomes

Thrombotic status

The main marker of interest is endogenous fibrinolysis time (LT)

Time frame

12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

East and North Hertfordshire NHS Trust

Lead sponsor

University of Hertfordshire

Sponsor institution

Liverpool Heart and Chest Hospital NHS Foundation Trust

Collaborator

Source ClinicalTrials.gov

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